2023 Biosimilars Report - Tracking market expansion and sustainability amidst a shifting industry
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2023 Biosimilars Report Tracking market expansion and sustainability amidst a shifting industry
INTRODUCTION
Welcome to our 2023
Biosimilars Report
Cardinal Health works with stakeholders across the healthcare continuum providing
support as they navigate the evolving biosimilars landscape to support care for
patients. From working with manufacturers to gain regulatory approval to distributing
biosimilars to providers and pharmacies, we have the unique opportunity to gather
insights about the interaction with and adoption of this new class of therapies.
Since we released our last report, the biosimilars market has continued to expand both
in scope and utilization. Our analysts predicted that 2022 would be a turning point
for biosimilars in the U.S., and we witnessed first-hand the expansion of biosimilars
into a new therapeutic area (ophthalmology), the push for competition as more
manufacturers submitted their biosimilars for interchangeability designations, and a
handful of new approvals and commercial launches.
As we look toward what’s next, we begin to see how this momentum in the biosimilars
space will actualize the promise of patient accessibility and affordability for some
of the costliest and critical treatments on the market. In fact, 2023 marks the end of
exclusivity for the world’s top-selling drug, Humira™ (adalimumab), and we expect new
competition from at least eight biosimilars.
In this report, we analyze the perspectives of more than 350 providers in the
therapeutic areas with the most potential for disruption in the year ahead:
rheumatology, gastroenterology, dermatology and ophthalmology. Combined with
perspectives from leading experts, we give a view of the industry and the imminent
market shift that will come from competition with Humira™ and biosimilar utilization.
We also analyze the latest industry data on utilization, government pricing reform, and
payer coverage.
With more than 50 blockbuster biologics set to lose exclusivity in the next decade,
the adoption of biosimilars can greatly affect the trajectory of healthcare costs and,
ultimately, patient access. Cardinal Health remains committed to helping our customers
improve patient health outcomes by supporting biosimilar development and adoption.
Sincerely,
Debbie Weitzman
CEO, Pharmaceutical Segment
Cardinal Health
2
Table of contents
• 2022 Biosimilars • Government
landscape Relations analysis
• Provider trends • A look ahead
• Rheumatology
• New and upcoming
• Gastroenterology biosimilars launches
• Dermatology • Adalimumab biosimilars
pipeline
• Adalimumab biosimilars
• Ophthalmology
3
2022 BIOSIMILARS LANDSCAPE
Reviewing the 2022
biosimilars landscape
4
2022 BIOSIMILARS LANDSCAPE
Introduction
In the first month of 2023, the top Biosimilar Medicines Savings Report from
healthcare story was the launch of the the Association for Accessible Medicines
first of at least 8 expected Humira™ (AAM), biosimilars were responsible for
Bruce Feinberg, DO biosimilars. These biosimilars will compete driving savings of $7 billion in biologic
VP and Chief Medical Officer
with the number one drug in worldwide spending in 2021 alone. According to the
sales for nearly a decade, after six years report, cumulative savings since 2015
of regulatory delay. As big as this story is, have now climbed to $13 billion.2 Within
the backstory may be bigger. This year’s the provider networks of Cardinal Health,
annual report continues that backstory as we’ve seen purchase cost savings exceed
we review highlights and insights from the $3 billion over our last four fiscal years
biosimilar marketplace in 2022. from the transition to biosimilar products.3
From slower beginnings, biosimilars
Th U.S. market now has 40 FDA-approved
have developed into an integral class of
biosimilar products with 25 commercially
products driving substantial cost-savings
available, including four products with an
for some of the most expensive biologic
interchangeable designation. Biosimilar
treatments available.
adoption has continued to grow year-
over-year in almost all product classes With seven new approvals, and several
facing competition, with several classes new commercial launches, 2022 brought
experiencing high single-digit, or even, much excitement. The following represent
double-digit adoption growth.1 But what we feel to be some of the most
perhaps most importantly, according to noteworthy milestones.
the most recent 2022 U.S. Generic and
5
2022 BIOSIMILARS LANDSCAPE
Milestone 1: The first biosimilar(s)
launch in ophthalmology
An interchangeability designation allows
After receiving initial FDA approval in for the biosimilar to be automatically
2021, the first biosimilar referencing
an ophthalmology product was
substituted for its reference product, per
officially launched in July 2022. state laws, and is generally most relevant
Byooviz™ (ranibizumab-nuna), the first
ophthalmology biosimilar product for products primarily dispensed in the
commercialized in the U.S. market by
Biogen (in partnership with Samsung pharmacy benefit.
Bioepis), launched with a significant 40%
discount to its reference product, Lucentis™
(ranibizumab) by Genentech.
Quickly following the launch of the Milestone 2: Growth in products nearly 20% of Americans resort to insulin
first ophthalmology biosimilar in the pursuing and achieving rationing.5 As this dynamic continues
U.S., a second ranibizumab biosimilar, interchangeability to play out, it highlights the significant
Cimerli™ (ranibizumab-eqrn), launched An important milestone achieved complexities within U.S. pharmaceutical
in October 2022 by Coherus Biosciences. in 2021 was the award of the first channels and brings to light the additional
In an interesting turn of events, this interchangeability designation in the U.S. adoption challenges biosimilars may face
second ranibizumab biosimilar was for insulin. Fast forward to a year later in the retail class of trade.
also awarded an interchangeability and we now have four interchangeable As the biosimilars market continues to
designation making it the first and only biosimilars: two long-acting insulin grow and shift more squarely into the
predominantly medical benefit biosimilar biosimilars, one adalimumab biosimilar, pharmacy benefit, we will expect to see
to achieve the designation thus far. and one ranibizumab biosimilar. As a commensurate growth in the number
Although the regulatory implications of reminder, interchangeability is a regulatory of products pursuing, and ultimately,
interchangeability (e.g., pharmacist-level designation, unique to the U.S. market, that achieving an interchangeability
substitution) are not as operationally allows for a biosimilar to be automatically designation. We anticipate many
relevant for provider-administered substituted for its reference product by a manufacturers of biosimilar assets will
products predominantly billed to a pharmacist (pharmacist-level substitution), view interchangeability in the pharmacy
patient’s medical benefit, the pursuit of per state laws. Interchangeability does not benefit as a competitive advantage
interchangeability can also be viewed as denote any clinical superiority over a non- and choose to conduct the additional
further supporting of a manufacturer’s interchangeable biosimilar. research generally required. Looking to
commercial strategy.
While adoption of Semglee™ (insulin 2023, at least four additional adalimumab
While it is still too early to tell as of this glargine-yfgn) has increased over the last biosimilar manufacturers are pursuing
writing how the early launches have fared year and now hovers around 10% market interchangeability. Beyond adalimumab,
from an adoption standpoint, we expect share4, we believe the transition to this several manufacturers have signaled
share shifts in the ophthalmology market first biosimilar insulin will be viewed by they plan to pursue interchangeability
to evolve more slowly as our market many as slower than expected considering for biosimilar candidates referencing
research data reveals significant provider the significant cost challenges facing ustekinumab, insulin aspart and
hesitation with biosimilars remains. insulin-dependent patients with diabetes. golimumab.
In an updated report, it was still cited that
6
2022 BIOSIMILARS LANDSCAPE
Figure 1. FDA-Approved Biosimilars
1st biosimilar Current # of biosimilar Biosimilar market Biosimilar share
Product Category
launch competitors share (Nov. 2022) change (since Nov. 2021)
Neupogen™ (filgrastim) Supportive care 2015 31 93%1 +2%
Remicade™ (infliximab) Immunology 2016 3 44% +12%
Epogen™/Procrit™ (epoetin alfa) Supportive care 2018 1 42% -10%
Neulasta™ (pegfilgrastim) Supportive care 2018 42 43% +4%
Avastin™ (bevacizumab) Oncology 2019 33 82% +7%
Herceptin™ (trastuzumab) Oncology 2019 5 67% +11%
Rituxan™ (rituximab) Oncology 2019 3 72% +7%
Lantus™ (insulin glargine) Diabetes 2020* 14 10% +7%
Lucentis™ (ranibizumab) Ophthalmology 2022 2 3% +3%
Humira™ (adalimumab) Immunology 2023 95 N/A N/A
10 Product classes 25
Enbrel™ (etanercept) Immunology 2029 2 Not launched
Market share data source: IQVIA: Accessed via IQVIA National Sales Perspective (NSP) SMART Data. Nov 2022
1. Includes Teva’s Granix™, which is technically not a biosimilar since it was filed prior to the enactment of the Biosimilar Approval Pathway.
2. Amneal’s Fylnetra™ has not launched yet; Fresenius Kabi’s Stimufend™ has not launched yet
3. Celltrion Vegzelma™ has not launched yet
4. Excludes Basaglar™ and yet to be launched Rezvoglar™
5. As of date of this publication, only 1 adalimumab biosimilar has launched
*Neulasta Syr. Only biosimilars share is 77%
Note: italicized represents approved biosimilars that have not launched in the U.S. yet
7
2022 BIOSIMILARS LANDSCAPE
Milestone 3: Unveiling Enhancing
Oncology Model (EOM) and
reauthorization of BsUFA III
With the former Oncology Care Model
(OCM) sunsetting on June 30, 2022,
the Centers for Medicare and Medicaid
Innovation (CMMI) unveiled a replacement
program named the Enhancing Oncology
Model (EOM) in June 2022. Unfortunately,
given delays in releasing the new
program, there will be a roughly 1-year
gap between the expiration of OCM and
the launch of EOM. EOM is now set to
launch July 1, 2023.6 EOM (like OCM) is a
5-year, voluntary model that will require
participating oncology practices to take
on both financial risk and performance
accountability for treating patients with
common cancer types. With a continued
focus on value-based patient care, EOM
aims to add an additional focus on health
equity along with added enhancements
gleaned from feedback on OCM from
providers, patients, and advocacy groups.
OCM proved to be a powerful model
that contributed, in part, to the dramatic October 2022 through September 2027.7 In October 2022, five research grants were
growth and adoption of biosimilars in These biosimilar user fees are dedicated awarded and funded by FDA as part of the
the oncology market. With a focus on to helping expedite the time needed to pilot.
providing high-quality cancer care, at review biosimilar applications for approval
With the reauthorization behind us, we
the lowest cost, biosimilars proved to be and facilitate timely access to safe and
can be further ensured of the regulatory
powerful tools in this value-based care effective biosimilar treatment options
commitment to timely review of biosimilar
environment. As the market prepares for patients. Additionally, the BsUFA III
assets in the pipeline and advancement of
for the launch of EOM, we are hopeful commitment letter also outlined the
biosimilar development policies in the U.S.
biosimilars will continue to be viewed as creation of a new biosimilar Regulatory
market.
integral in providing high-quality, low- Research Pilot Program. The Regulatory
cost, cancer care in the U.S. market. Research Pilot Program has two key
focuses:
Separately, on September 30, 2022,
President Biden signed into law the FDA 1. Improving the efficiency of biosimilar
User Fee Reauthorization Act of 2022, product development
which includes the Biosimilar User Fee
2. Advancing the development of
Act (BsUFA III). BsUFA III authorizes FDA
interchangeable products
to assess and collect fees for biosimilar
products over the 5-year period from
8
2022 BIOSIMILARS LANDSCAPE
Figure 2. Biosimilar market share (as of Sept. 2022)
100
90
80
70
60
Total biosimilar share (%)
50
40
30
20
10
0
Jan-16 Nov-16 Sep-17 Jul-18 May-19 Mar-20 Jan-21 Nov-21 Sep-22
Avastin™ Remicade™ Lantus™
Neupogen™ Herceptin™ Neulasta™
Epogen™/Procrit™ Rituxan™ Lucentis™
Market share data source: IQVIA: Accessed via IQVIA National Sales Perspective (NSP) SMART Data. Sept 2022
9
2022 BIOSIMILARS LANDSCAPE
Figure 3. Adoption speed (as of Sept. 2022)
100
90
80
70
60
Total biosimilar share (%)
50
40
30
20
10
0
0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80
Months since first biosimilar launched
Avastin™ Lantus™ Neupogen™
Epogen™ Lucentis™ Remicade™
Herceptin™ Neulasta™ Rituxan™
Neulasta™
Market share data source: IQVIA: Accessed via IQVIA National Sales Perspective (NSP) SMART Data. Sept 2022
102022 BIOSIMILARS LANDSCAPE
Milestone 4: Inflation Reduction Act
Signed into law in August 2022, the
Inflation Reduction Act (IRA) has several "Biosimilars continue to
direct, and indirect, connections to the
biosimilars market. Given the potentially hold significant promise
significant impact of this new legislation,
we have chosen to dedicate an entire
to positively impact
section of our report to review and focus
on the biosimilar-specific implications of
patient care for millions
the IRA. Suffice it to say, there are too many
noteworthy implications for biosimilars in
in the U.S. and globally."
the IRA to do it justice in our introduction
alone. From changes to reimbursement
add-on rates in Medicare Part B, to indirect
The clarity that potentially several Conclusion
impacts on determining which products
adalimumab biosimilars will become While much has changed, the continued
are eligible for Medicare negotiation,
preferred products on major PBM need for multi-stakeholder education,
biosimilars are a key topic in the IRA. Our
formularies in 2023 is cause for celebration. awareness and dedicated research remains
more detailed review on the IRA can be
However, with current indications that even more important as we expand into
found on page 57.
reference adalimumab will also be retained newer therapeutic areas and classes
as a preferred product along with the of trade. To that end, the Accreditation
Milestone 5: Early indications of
biosimilars (known as parity coverage), Council for Medical Affairs (ACMA) has
formulary coverage for adalimumab
it will be difficult to gauge how much created the Board Certified Biologics and
biosimilars
utilization will transition to the biosimilars Biosimilars Specialists Program (BCBBS)
One of the biggest previously unanswered in 2023. Assessing the pros and cons of a a on-line, self-paced, 9-module, 40 hour
questions regarding the adalimumab potential patient transition will become curriculum to establish expertise among
biosimilar "event" was whether these increasingly important for patients healthcare professionals. Biosimilars will
products would be able to gain coverage and providers. Patient out-of-pocket continue to hold significant promise to
on payer/pharmacy benefit management costs between the reference product positively impact patient care for millions
(PBM) formularies quickly. January 2023 and biosimilars, comparing product in the U.S. and globally. In this, our 2023
represents a watershed moment for the differences (e.g., citrate-free, concentration Biosimilars Report, we are proud to bring
biosimilars market as the first adalimumab differences, device differences), presence you new perspectives and insights from
biosimilar is finally expected to launch of an interchangeability designation and a new slate of key opinion leaders across
commercially in the U.S. after originally the level of manufacturer wrap around four therapeutic areas. As an organization,
receiving FDA approval in September 2016.8 patient support programs will all add to we remain committed to playing a key
Several additional biosimilars are expected this complexity. role in creating awareness of biosimilar
to launch mid-year, including at least one
We expect this year will be filled with products and increasing education across
biosimilar carrying an interchangeability
much analysis and discussion regarding our industry.
designation. As of our writing, two major
PBMs (OptumRx and Express Scripts) adalimumab’s official loss of exclusivity and
have issued public statements indicating anticipate the entire healthcare industry
that they plan to cover both reference will be watching for early signs of adoption,
adalimumab and several adalimumab potential cost-savings and increased access
biosimilars once available. for patients in one of the costliest disease
states globally.
11Provider trends
As the U.S. biosimilars market continues dynamic for these providers and raises the
to grow and expand into additional importance of how they view biosimilars
therapeutic areas, understanding the as an available option. To capture this
provider experience across various dynamic, we expanded our provider
specialties has become even more surveys to include gastroenterologists
important. and dermatologists, accompanying the
rheumatology and ophthalmology research
With the largest loss of exclusivity event,
we’ve begun collecting over the last few
perhaps ever in the U.S., set to take place
years.
for Humira™ (adalimumab) in 2023,
providers that treat immune-mediated This research provides unique insights
inflammatory diseases will be presented and views of each provider group, and
with more treatment options for their better showcases their familiarity with
patients than ever before. While overall biosimilars, concerns with prescribing and
biosimilar adoption has increased over the expected utilization as new biosimilars
past year, certain therapeutic areas that come to market. Insights are taken from our
are less experienced with these products– most recent healthcare provider surveys
like dermatology and ophthalmology– conducted between July – October 2022,
continue to face additional barriers with commentary and analysis provided by
to adoption. This poses an interesting leading physicians in each therapeutic area.
12PROVIDER TRENDS
Most participating physicians cited Ophthalmology N = 64
familiarity with biosimilars and the Rheumatology N = 103
Dermatology N = 126
interchangeability designation. Gastroenterology N = 72
81%
Figure 4.
76%
How would you describe your
familiarity with biosimilars?
55% 56%
33%
31%
22%
18%
12% 13%
2% 1%
Very familiar Somewhat familiar Not very familiar
61%
Figure 5.
How would you describe 52%
your familiarity with the 47%
46% 46%
interchangeability designation 42%
for biosimilars?
27%
25%
21%
14%
11%
8%
Very familiar Somewhat familiar Not very familiar
13PROVIDER TRENDS
Provider views on the discount needed Ophthalmology N = 64
to motivate a switch to a biosimilar Rheumatology N = 103
Dermatology N = 126
varied by specialty. Gastroenterology N = 72
40%
36%
31%
29%
25%
Figure 6.
21%
If you assume all clinical
17%
factors to be equal, how
14%
much of the discount from 11%
13%
the reference product would 9%
be necessary for you to 4%
prescribe a biosimilar versus
the reference product?
Greater than 40% 31-40% 21-30%
24%
20%
19%
16%
13%
11%
10% 10%
9%
8%
7%
3%
0% n/a n/a n/a
11-20% 5-10% Less than 5% None, I am not
likely to prescribe
a biosimilar
1415
RHEUMATOLOGY TRENDS
Biosimilars in rheumatology:
The forthcoming season of
change in 2023
Jeffrey R. Curtis, MD, MS, MPH
Professor of Medicine, Division of Clinical Immunology & Rheumatology, UAB
This upcoming year will yield important having biosimilars were not favorable to whether they were receiving one of
transitions in the treatment landscape enough to motivate switching. Both the several biosimilars or the reference
for inflammatory conditions once self- biosimilar efficacy, and the lack of economic product. In contrast, for a forthcoming
administered biosimilars enter the benefit (to patients and/or to providers), self-administered injectable therapy
rheumatology market. Beginning first with were rheumatologists’ top concerns related like biosimilar adalimumab, the need
Amjevita™ (adalimumab-atto) in the first to increasing uptake. Not surprisingly, the to educate patients will become more
quarter of 2023, followed by at least seven group of patients where there was the pressing and will put additional burden
more in the months to follow, the impact greatest comfort to use a biosimilar was on rheumatologists and their office staff.
on rheumatology patients, their providers, for patients initiating therapy, rather than Of note, 47% of rheumatologists did not
and office staff likely will be profound. A those who were already established on a indicate that they were ‘very comfortable’
survey of 103 rheumatologists conducted reference biologic treatment. with discussing the option with patients,
by Cardinal Health in July and August of suggesting an important need to train
Several therapy-specific features were
2022 provides helpful insights into what rheumatology providers and their staff on
found to be important to rheumatologists
rheumatologists believe, and subsequently how to effectively educate their patients
and their patients. For example, the product
may do, as it relates to biosimilars. regarding biosimilar use.
attributes of biosimilar adalimumab that
Based on the survey results, while most rheumatologists rated as ‘very important’ Ultimately, biosimilars need to deliver on
rheumatologists (76%) stated that they were a citrate-free formulation (62%) their oft-promised savings and deliver
are ‘very familiar’ with biosimilars and 62% and an interchangeability designation value to all stakeholders. For rheumatology
said that they would be ‘very comfortable’ (60%). Beyond those, one of the biggest patients with adequate commercial
with prescribing, the motivations and potential threats to realizing the potential insurance coverage, biosimilars may
concerns of rheumatologists elicited for biosimilars to save cost and improve offer little upside, and may be met with
important learnings. First, there was some access is the need for patient education. Of skepticism as to their benefit. Ensuring that
ambivalence among rheumatologists survey respondents, 85% agreed or strongly all stakeholders’ needs are met to affect a
about the opportunities with biosimilars. agreed that patient education would smooth transition to biosimilars remains an
Only about half (54%) agreed or strongly be important. Patient education needs important challenge in the year to come.
agreed that biosimilars would positively regarding self-administered biosimilars
impact care. About the same proportion will be a unique feature in 2023 compared
were not excited about the growing to past years when only intravenous
number of biosimilars anticipated to come formulations were available. Given that
to market. Secondly, given the anticipated all rheumatology biosimilars available in
cost-savings and hoped-for improvement the U.S. to date (e.g., infliximab, rituximab)
in access to care, the median discount have been provider-administered, the
that rheumatologists expected to see need for patient education has been less
with biosimilars to consider transitioning pronounced. Indeed, many rheumatology
a patient was 21-30%. Importantly, more patients receiving an intravenously
than half of rheumatologists felt that the administered biologic like infliximab
economic benefits observed to date from may have had little to no awareness as
16RHEUMATOLOGY TRENDS
Most rheumatologists surveyed said they are very comfortable
prescribing biosimilars, particularly for new patients and
existing patients for whom payers have mandated a biosimilar.
Figure 7. How comfortable do you feel prescribing biosimilars to your patients?
N = 103
62% 32% 6%
Very comfortable Somewhat comfortable Not very comfortable
Figure 8. For which patients are you most likely to prescribe a biosimilar?
N = 103
41% 40% 9% 4% 6%
Existing patients for New patients Existing patients Existing patients having I am not likely
whom payers have having success on a limited success on a to prescribe a
mandated a biosimilar reference product reference product biosimilar for any
patient at this time
85% of participating rheumatologists
said educating patients about
biosimilars is important.
17RHEUMATOLOGY TRENDS
About half of the surveyed rheumatologists are excited about
the growing number of biosimilars coming to market.
Figure 9. To what extent do you agree with the following statement? I am excited about the growing
number of rheumatology biosimilars anticipated to come to market.
N = 103
13% 34% 33% 15% 5%
Strongly agree Agree Neither agree Disagree Strongly disagree
nor disagree
18RHEUMATOLOGY TRENDS
Participating rheumatologists cited citrate-free formulation
and interchangeability as the most important product
attributes for prescribing an adalimumab biosimilar.
Figure 10. How important are the following product attributes Very important
when it comes to utilizing an adalimumab biosimilar? Somewhat important
N = 103 Not important at all
62% 60%
54%
50%
47% 46%
43% 43%
36%
33%
7% 5% 7%
3% 4%
Concentration Citrate-free Latex-free Device Interchangeability
Figure 11. To what extent do you agree with the following statement? I believe that biosimilars will
positively impact rheumatology care.
N = 103
15% 38% 32% 13% 2%
Strongly agree Agree Neither agree Disagree Strongly disagree
nor disagree
More than 50% of rheumatologists surveyed believe
biosimilars will positively impact care for their patients.
19RHEUMATOLOGY TRENDS
Concerns about efficacy and lack of economic benefit are
viewed as the primary barriers to adoption for participating
rheumatologists.
Figure 12. Which of the following is your top concern about prescribing biosimilars?
N = 103
Concerns about efficacy of biosimilars Lack of payer adoption
36% 10%
Concerns about lack of economic benefit Concerns about manufacturing
24% 7%
Evaluating when to prescribe a biosimilar versus Providing patient education
a reference product 6%
17%
Figure 13. To what extent do you agree with the following statement? Today, the economics of biosimilars
are not favorable enough to motivate me to switch from the reference products.
N = 103
19% 35% 28% 15% 3%
Strongly agree Agree Neither agree Disagree Strongly disagree
nor disagree
Less than one in five 53% of participating
rheumatologists (18%) surveyed rheumatologists cited feeling
believe that today's biosimilar very comfortable
economics are favorable discussing biosimilar
enough to motivate options with patients.
them to switch.
20RHEUMATOLOGY TRENDS
More than two-thirds of participating rheumatologists said
they are at least somewhat comfortable switching from one
biosimilar to another.
Figure 14. How comfortable
do you feel switching from
one biosimilar to another?
N = 103 18% 52% 20% 10%
Very comfortable Somewhat Somewhat Very uncomfortable
comfortable uncomfortable
21GASTROENTEROLOGY TRENDS
Defining the place of
biosimilars in gastroenterology
Vivek Kaul, MD, FACG, FASGE, AGAF, NYSGEF
Professor of Medicine, University of Rochester, NY
The advent of biologic therapy (TNF When considering the option of
inhibitors) has transformed the prescribing an adalimumab biosimilar,
management of patients with IBD clinical and/or real-world evidence
(inflammatory bowel disease) over the studies were cited as playing a key role
last two decades. The introduction of in medical decision-making, along with
biosimilars in this realm presents an consideration for patient out-of-pocket
opportunity to provide comparable cost and payer coverage. Based on this
products to patients at a lower cost. In a survey, the top concerns for adalimumab
recent survey of 72 gastroenterologists biosimilars include transitioning patients
conducted by Cardinal Health, 80% from Humira™ to a biosimilar (44%) and
responded that they are very familiar the interchangeability of biosimilars (38%).
with biosimilars. All physicians reported Patient education regarding biosimilar
being very comfortable (or somewhat safety, efficacy and interchangeability
comfortable) prescribing these agents. In appears paramount to the acceptance of
fact, over 95% of those who responded to these products, particularly for patients
the survey had prescribed an infliximab who are switched from a reference product.
biosimilar in the prior 12-month period.
Despite general acceptance of biosimilars,
While gastroenterology has lagged there remains some uncertainty regarding
behind other specialties (e.g., oncology) their place in the current gastroenterology
in the biosimilar space, the availability landscape. This is likely because only
and utilization of and the competition of half of the survey respondents believed
these agents with their reference products, that biosimilars will positively impact
is expected to significantly increase in gastroenterology care, further highlighting
2023 with the release of at least seven the ongoing need for real-world data
adalimumab biosimilars. Nearly all (93%) of and incorporation of biosimilar use and
the physicians surveyed indicated they are interchangeability into clinical guidelines.
at least somewhat comfortable prescribing Additionally, there continues to be
an adalimumab biosimilar once it becomes concern over payer coverage and patient
available. This survey indicated that out-of-pocket costs which may impact
biosimilars are prescribed most commonly their utilization. Despite these challenges,
for new patients or patients for whom a we anticipate that the rapid growth of
payer requires a biosimilar, although this biosimilars will play a greater role in clinical
paradigm may change with the addition practice and reimbursement models of
of more biosimilar options, along with the future.
payer and gastroenterologist stakeholder
adoption in the future.
22GASTROENTEROLOGY TRENDS
All surveyed gastroenterologists said they are at least
somewhat comfortable prescribing biosimilars for patients,
primarily to new patients and those for whom payers have
mandated a biosimilar.
Figure 15. How comfortable do
you feel prescribing biosimilars
86% 14% 0%
to your patients?
N = 72
Very comfortable Somewhat comfortable Not very comfortable
Figure 16. For which patients are you
most likely to prescribe a biosimilar?
49% 36% 7%
N = 72
Existing patients for New patients Existing patients having
whom payers have limited success on a
mandated a biosimilar reference product
5% 3%
Existing patients I am not likely
having success on a to prescribe a
reference product biosimilar for any
patient at this time
2324
GASTROENTEROLOGY TRENDS
More than 60% of gastroenterologists surveyed believe
biosimilars will positively impact care in gastroenterology.
Figure 17. To what extent do you agree with the following statement?
I believe that biosimilars will positively impact gastroenterology care.
N = 72
33% 31%
28%
5% 3%
Strongly agree Agree Neither agree Disagree Strongly disagree
nor disagree
Half of gastroenterologists are excited and a third are
indifferent on how they feel about the growing number of
biosimilars anticipated in gastroenterology with the top
response being neutral.
Figure 18. To what extent do you agree with the following statement? I am excited about the growing
number of gastroenterology biosimilars anticipated to come to market.
N = 72
35%
28%
22%
11%
4%
Strongly agree Agree Neither agree Disagree Strongly disagree
nor disagree
25GASTROENTEROLOGY TRENDS
Participating gastroenterologists cite concerns about
biosimilar efficacy, providing patient education, and lack of
economic benefit as primary barriers to adoption.
Figure 19. Which of the following is your top concern about prescribing biosimilars?
N = 72
Concerns about efficacy of biosimilars Lack of payer adoption
31% 14%
Providing patient education Evaluating when to prescribe a biosimilar versus a reference product
18% 12%
Concerns about lack of economic benefit Concerns about manufacturing
17% 8%
Figure 20. To what extent do you agree with the following statement? Educating patients about
biosimilars as safe and effective treatment options is important.
N = 72
35% 49% 14% 1% 1%
Strongly agree Agree Neither agree Disagree Strongly disagree
nor disagree
Nearly 100% of gastroenterologists surveyed feel at least somewhat
comfortable discussing biosimilar options with patients.
26GASTROENTEROLOGY TRENDS
Participating gastroenterologists are divided on the issue of
whether the economics of biosimilars are favorable enough
to motivate a switch from reference products.
Figure 21. To what extent do you agree with the following statement? Today, the economics of biosimilars
are not favorable enough to motivate me to switch from the reference products.
N = 72
14% 22% 29% 29% 6%
Strongly agree Agree Neither agree Disagree Strongly disagree
nor disagree
36% of gastroenterologists surveyed believe the economics
of biosimilars are favorable enough to motivate a switch.
27GASTROENTEROLOGY TRENDS
Nearly 80% of gastroenterologists surveyed said they are at
least somewhat comfortable switching from one biosimilar
to another.
Figure 22. How
comfortable
33% 46% 17% 4%
do you feel
switching from
one biosimilar
to another?
N = 72
Very comfortable Somewhat Somewhat Very uncomfortable
comfortable uncomfortable
28GASTROENTEROLOGY TRENDS
Participating gastroenterologists cited device ease-of-
use, citrate-free formulation, and interchangeability as the
most important attributes for prescribing an adalimumab
biosimilar.
Figure 23. 46% 67% 44%
47% 26% 42%
How important are the following 7% 7% 14%
product attributes when it comes to
utilizing an adalimumab biosimilar?
Very important
Somewhat important
Not important at all Concentration Citrate-free Latex-free
70% 65%
29% 32%
1% 3%
Device Interchangeability
More than 95% of surveyed gastroenterologists said
that the device and interchangeability were at least
somewhat important when determining to utilize an
adalimumab biosimilar.
29DERMATOLOGY TRENDS
Will safety concerns impact
dermatologist adoption of biosimilars?
Alex S. Gross, MD
Medical Director, Northside Hospital Forsyth
Dermatologists believe biosimilars cited in this survey. When it comes to how
will positively impact care, but safety/ providers review new products, the three
efficacy concerns may impact adoption. most important considerations in the
The imminent launch of at least seven review hierarchy are safety, efficacy and
adalimumab biosimilars in 2023 is expected accessibility. I see this clearly reflected in
to greatly impact competition and the the responses from the survey with safety/
availability of biologic treatment options efficacy concerns representing the highest
in the dermatology space. With the ranked results when asked about the top
approaching growth of biosimilar options concern of prescribing biosimilars (47%)
in dermatology, Cardinal Health surveyed and top concerns when considering future
126 dermatologists in September of 2022 to adalimumab biosimilars (70%).
better understand how they plan to adopt
Similar to other therapeutic areas, adoption
these biosimilars into their prescribing
of biosimilars can be influenced by more
patterns and uncover any potential
than just physician prescribing patterns.
roadblocks.
Patient out-of-pocket costs and managed
Compared to other therapeutic areas which care strategies will play key roles in the
have, historically, not been receptive to utilization of these products in the future. In
new products like biosimilars at the onset, fact, we see from the results that over 50%
an overwhelming 80% of respondents of respondents noted that they are most
reported being at least somewhat likely to prescribe a biosimilar for existing
comfortable prescribing a biosimilar. patients for whom payers have mandated
Of those respondents, 75% specifically a biosimilar. Further, 65% of dermatologists
noted being comfortable prescribing an stated that patient out-of-pocket costs
adalimumab biosimilar once it becomes would be a key-decision criteria for
available. As part of the survey, they also prescribing an adalimumab biosimilar once
indicated that the ease of use of the device available.
(72%) and presence of an interchangeability
Despite these challenges, dermatologists
designation (69%) would be the most
appear optimistic about the potential for
important product attributes when deciding
biosimilars to positively impact dermatology
to prescribe an adalimumab biosimilar.
care once available to them and their
Despite the relatively high level of patients. Real-world evidence, both
prescribing comfort dermatologists international or domestic, was most cited
displayed in their responses, less than 20% as an important factor to support clinical
of respondents have prescribed a biosimilar confidence in using adalimumab biosimilars
within the last 12 months, indicating in the future. With robust utilization of
limited use of infliximab biosimilars — the adalimumab biosimilars internationally for
only biosimilars currently approved for several years, I believe this type of data will
dermatologic indications. This may indicate serve as a strong tool to address existing
that future product adoption could be concerns around the safety and efficacy of
slower than one would expect despite the biosimilar products.
30 relative familiarity and comfort prescribingDERMATOLOGY TRENDS
80% of dermatologists surveyed are at least somewhat
comfortable prescribing biosimilars, primarily to existing
patients for whom payers have mandated a biosimilar.
Figure 24. How comfortable
do you feel prescribing
35% 45% 20%
biosimilars to your patients?
N = 126
Very comfortable Somewhat comfortable Not very uncomfortable
Figure 25. For which patients are you
most likely to prescribe a biosimilar?
N = 126
Existing patients for whom payers
have mandated a biosimilar
51%
New patients
18%
Existing patients having limited
success on a reference product
13%
Existing patients having success on a
reference product
9%
I am not likely to prescribe a biosimilar
for any patient at this time
9%
31DERMATOLOGY TRENDS
53% of the surveyed dermatologists believe biosimilars will
positively impact care.
Figure 26. To what extent do you agree with the following statement? I believe that biosimilars will
positively impact dermatology care.
N = 126
13% 40% 32% 13% 2%
Strongly agree Agree Neither agree Disagree Strongly disagree
nor disagree
41% of participating
dermatologists say they are
excited about the growing
Only 15% of dermatologists number of dermatology
surveyed disagree or strongly biosimilars anticipated
disagree that biosimilars will to come to market while
positively impact care. another 40% are neutral.
32DERMATOLOGY TRENDS
Efficacy of biosimilars is cited as the top concern for
participating dermatologists.
Figure 27. Which of the following is your top concern about prescribing biosimilars?
N = 126
Concerns about efficacy of biosimilars Concerns about lack of economic benefit
48% 10%
Evaluating when to prescribe a biosimilar versus Concerns about manufacturing
a reference product 9%
14%
Providing patient education
Lack of payer adoption 6%
13%
Figure 28. To what extent do you agree with the following statement? Today, the economics of biosimilars
are not favorable enough to motivate me to switch from the reference products.
N = 126
16% 31% 41% 10% 2%
Strongly agree Agree Neither agree Disagree Strongly disagree
nor disagree
Nearly 50% of dermatologists surveyed agreed or strongly
agreed that the economics of biosimilars are not favorable
enough to motivate a switch from reference products.
33DERMATOLOGY TRENDS
Nearly three out of four dermatologists surveyed are at least
somewhat comfortable discussing biosimilar options with
patients.
Figure 29. How
comfortable do
33% 41% 20% 6%
you feel discussing
biosimilar options
with your patients?
N = 126
Very comfortable Somewhat Somewhat Very uncomfortable
comfortable uncomfortable
82% of participating dermatologists strongly agree
or agree that educating patients on the safety and
effectiveness of biosimilars is a key priority.
34DERMATOLOGY TRENDS
About 60% of dermatologists surveyed said they are at least
somewhat comfortable switching from one biosimilar to
another.
Figure 30. How
comfortable
12% 47% 32% 9%
do you feel
switching from
one biosimilar
to another?
N = 126
Very comfortable Somewhat Somewhat Very uncomfortable
comfortable uncomfortable
Participating dermatologists cited device ease-of-use and
interchangeability as the most important attributes when
deciding to utilize an adalimumab biosimilar.
Figure 31.
How important are the following
48% 46% 46% 45%
product attributes when it comes to 43% 41%
utilizing an adalimumab biosimilar?
13%
9% 9%
Very important
Somewhat important
Not important at all Concentration Citrate-free Latex-free
72% 70%
25% 25%
3% 5%
Device Interchangeability
35ADALIMUMAB BIOSIMILARS
Provider
perspectives on
adalimumab
biosimilars
The 2023 Biosimilars Report would not Overall, providers appear to be generally With eight already FDA-approved
be complete without a dedicated review comfortable prescribing an adalimumab biosimilar versions scheduled to launch
of the adalimumab biosimilar event biosimilar once available with at least throughout 202310, to say the biosimilar
scheduled to transpire over the course 75% of providers surveyed across bench is deep is an understatement.
of 2023. Arguably the single largest rheumatology, gastroenterology and Since first launching in 2003, adalimumab
pharmaceutical loss of exclusivity (LOE) dermatology stating that they were at least as a product has evolved in many ways
event of all time, the LOE of Humira™ somewhat comfortable with this practice. including new concentrations, citrate-
(adalimumab) is poised to change the Gastroenterologists appear to be the free versions, latex-free delivery devices
biosimilar landscape as we know it. To most comfortable provider type with 50% and smaller needle gauges. Given the
better understand the implications of this of specialists in this area indicating they numerous product attributes that have
biosimilar event, we surveyed providers would be very comfortable prescribing been introduced over the last 18 years,
across rheumatology, gastroenterology/ an adalimumab biosimilar once available. understanding what to anticipate from a
GI and dermatology (key therapeutic This is an interesting result given previous product differentiation standpoint will be a
areas that make up the vast majority of market research revealed gastroenterology challenging task for providers and patients.
indications approved for adalimumab) to specialists have historically been some When asked what product attributes would
capture their insights and perspectives. of the most hesitant providers to accept be most important when deciding to utilize
biosimilars.9 an adalimumab biosimilar; the device’s
36ADALIMUMAB BIOSIMILARS
ease of use, interchangeability and citrate- interchangeability designation.” These (RWE) studies, patient out-of-pocket
free formulations rose to the top of the list. results suggest that further efforts costs and payer coverage each occupied
Product concentration and the presence are needed to strengthen education top spots in this category followed by
of latex in the device were viewed as less on interchangeability in the provider price/cost discounts to the practice, and
important attributes when compared community. manufacturer’s supply reliability.
against the full slate. An interesting point
When discussing their top concerns When asked what would best support their
to note is that despite all provider types
regarding adalimumab biosimilars, safety clinical confidence in utilizing adalimumab
citing that interchangeability would be a
and efficacy, interchangeability and having biosimilars with new and existing
key product attribute when deciding to
substitutions at the pharmacy level and patients, the top response with at least
use a biosimilar adalimumab, less than
transitioning a patient from adalimumab to 40% of providers across all therapeutic
50% of providers across all therapeutic
an adalimumab biosimilar rose to the top areas was RWE, both international and
areas described their familiarity with the
as of most concern. These were followed domestic, followed distantly by acceptance
interchangeability designation as “very
closely by no cost savings to patients into clinical guidelines for practice
familiar.” Further, an average of 64% of
and payer coverage decisions. Surveyed management. These findings further
providers surveyed agreed or strongly
providers’ top concerns correlated strongly highlight the continued need for education
agreed with the statement that they
with their key decision criteria for deciding to strengthen clinical confidence in these
“will only feel comfortable prescribing
when to utilize an adalimumab biosimilar. agents and help overcome key barriers to a
an adalimumab biosimilar if it has an
Clinical and/or real-world evidence more robust biosimilars market in the U.S.
37ADALIMUMAB BIOSIMILARS 38
ADALIMUMAB BIOSIMILARS
93% of gastroenterologists said they are at least somewhat
comfortable prescribing adalimumab biosimilars compared to
86% for rheumatologists and 75% of dermatologists.
Gastroenterologists reported the highest comfort levels
with adalimumab biosimilars compared to dermatologists
and rheumatologists.
Figure 32. 50% 49%
44%
How comfortable are you 43%
37%
prescribing an adalimumab 31%
biosimilar to your patients,
19%
once available? 12%
6%
4% 3% 3%
Dermatology N = 126 Very comfortable Somewhat Somewhat Very
Rheumatology N = 103 comfortable uncomfortable uncomfortable
Gastroenterology N = 72
39ADALIMUMAB BIOSIMILARS
Attitudes about which product attributes are most important
when deciding to utilize an adalimumab biosimilar were
generally similar across specialties.
How important are the following product attributes when it comes to utilizing an adalimumab biosimilar?
Figure 33. Figure 34.
Concentration Citrate-free
62% 67%
48% 46% 50% 47% 46%
43% 43% 41%
33%
26%
9% 13%
7% 7% 5% 7%
Very important Somewhat Not important Very important Somewhat Not important
important at all important at all
Figure 35. Figure 36.
Latex-free Device (e.g., ease of use)
72% 69%
54%
46% 47% 44% 45% 46% 42% 43%
25% 29%
9% 14%
8% 3% 3% 1%
Very important Somewhat Not important Very important Somewhat Not important
important at all important at all
Figure 37.
Interchangeability Designation
70% 65%
60%
36% 32%
25%
5% 4% 3%
Very important Somewhat Not important
important at all
40ADALIMUMAB BIOSIMILARS
Figure 38.
To what extent do you agree with the Over 60% of providers
following statement? I will only feel comfortable
across all therapeutic areas will
prescribing an adalimumab biosimilar if it has the
interchangeability designation. only feel comfortable prescribing
an adalimumab biosimilar if it has
an interchangeability designation
44%
41%
39%
28% 28%
25% 25%
22%
18%
11%
9%
6% 6%
3% 3%
Strongly agree Agree Neither agree nor Disagree Strongly disagree
disagree
Dermatology N = 126
Rheumatology N = 103
Gastroenterology N = 72
Product attributes most commonly cited as “very important”
Dermatologists Rheumatologists Gastroenterologists
• Device/Ease of use (72%) • Citrate-free (62%) • Device/Ease of use (69%)
• Interchangeability (70%) • Interchangeability (60%) • Citrate-free (67%)
4142
ADALIMUMAB BIOSIMILARS
Safety and efficacy of adalimumab biosimilars were
the top concerns for participating dermatologists and
rheumatologists, while gastroenterologists were most
concerned about transitioning patients from adalimumab
to an adalimumab biosimilar.
Figure 39. 70%
64%
What are your top concerns
regarding adalimumab
biosimilars? Please select up to 3. 47%
43%
38% 39%
37%
35%
33%
Dermatology N = 126
Rheumatology N = 103
Gastroenterology N = 72
Safety and effficacy Interchangeability No cost savings
and having to patients
substitutions at the
pharmacist level
44%
40% 39%
37%
25% 25% 24%
22% 22%
19% 19%
17%
4%
1% 1%
0% 0% 0%
Transitioning Switching Payer or Pharmacy Lack of patient Other, please I have no
a patient from between Benefit Manager support programs specify hesitations about
adalimumab to adalimumab (PBM) coverage (e.g., patient prescribing
an adalimumab biosimilars decisions assistance adalimumab
biosimilar programs) biosimilars to my
patients
43ADALIMUMAB BIOSIMILARS
Across disciplines, participating specialists identified clinical
and real-world evidence and patient out-of-pocket costs as key
decision criteria when prescribing adalimumab biosimilars.
Figure 40.
What would be key decision criteria for utilizing an
adalimumab biosimilar? Please select up to 3.
32% 66% 62% 17% 65%
38% 62% 54% 15% 64%
33% 63% 43% 21% 58%
Cost/price discount Clinical and/or real- PBM/Payer coverage Manufacturer's supply Patient out-of-pocket
to the practice world evidence studies reliability cost
Figure 41.
Which of the following would best support your clinical confidence in utilizing
adalimumab biosimilars in both new and existing adalimumab-eligible patients?
45% 10% 17% 8% 19%
51% 7% 10% 12% 20%
46% 7% 11% 3% 33%
Real-world evidence, Real-world evidence, Uptake among my Greater information Acceptance into clinical
international or domestic only peers/colleages on FDA regulatory guidelines for patient
domestic approval process management
Dermatology N = 126
Rheumatology N = 103
Gastroenterology N = 72
4445
OPHTHALMOLOGY TRENDS
Biosimilars in ophthalmology:
hesitancy remains, but providers
showing positive acceptance
Arghavan Almony, MD
Partner and Vice President, Carolina Eye Associates
Although biosimilars have been utilized only 48% stated that they would prescribe
in oncology and rheumatology for years, biosimilars themselves. Additionally, half
ophthalmologists in the U.S. have had no of the respondents also stated they would
experience with these products until 2022. not prescribe a biosimilar without clinical
In September 2021, the first ranibizumab data to demonstrate safety and efficacy for
biosimilar (ranibizumab-nuna) was a specific indication, highlighting the need
approved by the FDA and launched in July for further data.
2022.11 A second (ranibizumab-eqrn) was
Despite these concerns, there does
approved in August 2022 with a launch in
appear to be overall positive acceptance
October 2022.12 Recently, Cardinal Health
of biosimilars in the retina space. In this
surveyed 64 retina specialists to gauge
survey, 73% of retina specialists reported
their understanding of, and patterns in,
that they would be likely to prescribe
adopting biosimilars in ophthalmology.
a biosimilar in neovascular age-related
While concerns over payer coverage and macular degeneration (nAMD), while
administrative burdens are at the top of 64% of retina specialists would be likely
the list, clinical questions of efficacy and to switch to a ranibizumab biosimilar for
safety appear to be one of the greatest a stable patient. Further, 71% would be
barriers to adoption of biosimilars among likely to switch to an aflibercept biosimilar
retina specialists. In the survey, physicians when it becomes available. Reasons for
were asked about clinical trial designs for this include the benefits of expanded
biosimilar development and in 2021 and drug options and potential to lower
2022, the majority of respondents (61% healthcare costs. Going forward, robust
and 57% respectively) felt that they either clinical trials, real-world data, concerted
had very limited knowledge of clinical trial efforts at educating retina specialists,
design or that the clinical trials are not reduced administrative burdens and
adequate to investigate biosimilar efficacy payer coverage will all prove to be critical
and safety. for wider adoption and acceptance of
biosimilars in ophthalmology. Biosimilars
Previous negative or unexpected
will also have to compete with new classes
experiences with newer retina products
of medications, such as faricimab, new
in the past decade have left many in the
platforms, such as Susvimo™ and its port-
profession leery of change. We see this
delivery device and off-label bevacizumab,
hesitation in the survey data which shows
which is both cheaper and carries 15
that although 67% of physicians felt that
years of data and experience with retina
the FDA approval process for biosimilars is
specialists.
sufficient to evaluate efficacy and safety,
46OPHTHALMOLOGY TRENDS
Introduction
The first ophthalmology biosimilar officially
launched in the U.S. in July 2022. Comparing
responses from retina specialists prior to the
launch last year with post-launch responses this
year, we examine the trends on how perceptions
of biosimilars have shifted, which can help
shed light on potential adoption patterns
and highlight obstacles that still need to be
overcome. This research was collected between
September – October 2022, via online surveys.
Participating ophthalmologists stated that the primary role of
biosimilars is to keep drug costs down, and that discounts play
a key role in decisions about switching to biosimilars.
Figure 42.
How do you
84% 31% 6% 6%
perceive the role
of biosimilars in
ophthalmology?
Please select all
that apply.
N = 64 Keep drug costs down Expand drug options Not needed as they Not needed as they are
are redundant to their becoming obsolete
biologic reference
product
47OPHTHALMOLOGY TRENDS
Top concerns among participating ophthalmologists include
payer coverage, lack of comfort from a clinical standpoint, and
administrative barriers (such as prior authorization processes).
Figure 43.
What are your primary concerns with prescribing biosimilars? Please select all that apply.
N = 64
Payer coverage concerns Not enough financial incentive
52% 31%
Uncomfortable from a clinical standpoint Other
48% 11%
Administrative barriers (e.g., prior authorization process) No concerns
45% 13%
About half of ophthalmologists surveyed believe the FDA
approval process for biosimilars is sufficient to evaluate their
efficacy and safety despite lack of clinical comfort being cited
as a top concern.
Figure 44.
Do you think the FDA approval process of biosimilars is sufficient to evaluate their efficacy and safety?
N = 64
Yes, and I do/will prescribe biosimilars No, and I will not prescribe biosimilars
48% 6%
Yes, but I do/will not prescribe biosimilars I am not familiar enough with biosimilars to assess
19% 27%
48OPHTHALMOLOGY TRENDS
Nearly 25% of surveyed ophthalmologists are either not
familiar with the FDA approval process for biologics or believe
there are no differences between the approval process
for chemical and biologic drugs. This shows the need for
additional education on the biologic and biosimilar approval
pathways.
Figure 45.
Which statement
6% 41% 36% 17%
best reflects your
knowledge of
the FDA approval
pathways for
chemical and
The FDA approval The FDA approval The FDA approval I have little knowledge
biologic drugs?
N = 64
pathways are the pathways are slightly pathways are completely on the FDA approval
same for chemical and different for chemical different for chemical and pathway for biologics.
biologic drugs. and biologic drugs. biologic drugs.
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