In perhaps the most significant moment for the U.S. biosimilars market to date, the first of eight FDA-approved Humira (adalimumab) biosimilars launched in the United States in January after years of regulatory delays.
As the world’s top-selling biologic drug, with annual sales topping $21 billion, Humira is used to treat a wide range of chronic conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, Crohn’s disease, juvenile idiopathic arthritis, ulcerative colitis, and uveitis.
Although AbbVie’s patent for Humira officially expired in 2016, the legal and regulatory delays paused competition for Humira until 2023. Now, with a host of competitors approved and planning to launch, Humira’s patent expiration is widely considered the largest loss of exclusivity (LOE) event in the history of the U.S. pharmaceutical industry.
The entirety of healthcare stakeholders is watching the biosimilars market closely because LOE events, particularly the Humira LOE, is likely to impact payers, providers, patients, and pharmaceutical manufacturers—both brand and biosimilar—and potentially society as a whole given the current controversy over rising drug prices. Starting with the first adalimumab biosimilar, Amgen’s Amjevita, which launched this January, the healthcare industry is wondering: how broadly will the respective stakeholders see the value and benefits of biosimilar competitors to one of the world’s top selling drugs?
While it may be 12 to 18 months before we see a significant biosimilar market penetration, stakeholders should be encouraged by several recent developments in both the provider and government policy sectors.
Growing Comfort Levels Among Providers
Biosimilar utilization has had steady growth in the U.S. since the first biosimilar launched in 2016, with more than a dozen branded drugs now with biosimilar competitors.
In Cardinal Health’s 2023 Biosimilars Report, which surveyed nearly 300 dermatologists, rheumatologists, gastroenterologists—all therapeutic areas that currently prescribe adalimumab—providers revealed that they are, overall, comfortable with the idea of prescribing an adalimumab biosimilar. In fact, 75% of the surveyed prescribers in all three therapy areas responded that they are at least somewhat comfortable with the products.
When broken out by therapeutic area, 76% percent of rheumatologists reported that they were “very familiar” with biosimilar products—a 43% increase over the 2022 survey. Meanwhile, 81% of gastroenterologists reported high levels of familiarity, while dermatologists reported less so with 31% familiarity.
Another interesting revelation is that the most important product attributes defined by surveyed prescribers differed by therapeutic area. Humira has evolved significantly since first launching in 2003 to include new concentrations, citrate-free versions, latex-free delivery devices, and smaller needle gauges, and each of the adalimumab biosimilars varies slightly with its approved product attributes. Our survey revealed that medical specialists also varied in regard to the attributes they found most valued:
- Rheumatologists cited citrate-free formulation and interchangeability
- Gastroenterologists cited ease-of-use, citrate-free formulation, and interchangeability
- Dermatologists cited ease-of-use and interchangeability
Safety and efficacy of adalimumab biosimilars continued to be a priority area of concern for providers with about 70% of dermatologists and 64% of rheumatologists citing it as a top concern, suggesting that manufacturers might look to make additional investments in research to achieve FDA interchangeability designation and provider education efforts.
Switching patients from brand to biosimilar, as well as between biosimilars, was also highlighted in the survey. Forty-four percent of gastroenterologists said switching patients was a top concern followed by 40% of dermatologists and 37% of rheumatologists.
Interchangeability designation was a strong positive attribute for providers. Though interchangeability, which allows a biosimilar to be automatically substituted for its reference product by a pharmacist (per state laws) does not denote any clinical superiority over a non-interchangeable biosimilar, more than 60% of providers, across all therapeutic areas, said they would be comfortable with providing an adalimumab biosimilar only if it has an interchangeability designation.
Following the first biosimilar achieving interchangeability designation in 2021, momentum continues to grow in both pharmacy and medical benefit biosimilars across therapy areas that many view as a product differentiator. Moreover, at least four additional adalimumab biosimilar manufacturers are pursuing interchangeability, while other drugmakers plan to pursue interchangeability for biosimilar candidates referencing ustekinumab, insulin aspart, and golimumab.
Despite the provider perceptions collected, there is often more to biosimilar adoption than simply comfort levels.
Policy and Payer Developments
Historically, we have seen that government and regulatory decisions can often have a major impact on the adoption of biosimilars.
Case in point: the Oncology Care Model which challenged oncologist’s status quo bias and resulted in significant increases in biosimilar prescribing in those participating in the Center for Medicare and Medicaid Innovation (CMMI) quality practice programs. Whether the CMMI’s Enhancing Oncology Model (EOM) has a similar impact remains to be seen.
Similarly, we expect that the Inflation Reduction Act (IRA), which President Biden signed into law in August 2022, will result in an increased adoption given the key provision that will pay providers an additional two-percentage point increase, or average sales price (ASP) plus 8%, effective October 1, 2022, for qualifying biosimilars. The increase, from ASP plus 6% to ASP plus 8%, will last for five years, and may help increase access to and utilization of biosimilars and promote competition in the marketplace.
In the 2023 Biosimilars Report, providers indicated concern with payer adoption of biosimilars, especially given that major pharmacy benefit manager (PBM) formularies are expected to retain reference adalimumab as a preferred product along with the biosimilars—something that could negatively affect the adoption rate of adalimumab biosimilars.
Financial incentives were explored further in the survey as biosimilars are expected to increase competition, thereby lower cost and increase access. Yet, many providers surveyed do not expect financial benefits for themselves or their patients. In fact, nearly 50% of dermatologists surveyed agreed or strongly agreed that the economics of biosimilars are not favorable enough to motivate a switch from a reference product. Similarly, 36% of gastroenterologists and only 18% of rheumatologists surveyed believe the economics of biosimilars are favorable enough to motivate a switch.
Our biosimilar research on prescriber patterns of care, choice architecture, and perceptions is now in its eighth year and has resulted in an extensive list of peer-reviewed publications as well as industry-facing reports. We’ve learned that this is a very complex marketplace that, unlike most drug classes which succeed or fail based on clinical trial outcomes of safety and efficacy, is influenced by healthcare policy, behavioral economics, medical benefit design, FDA, and regulatory processes. 2022 was a fascinating year for biosimilars, but may prove dull to 2023.