Survey Highlights the Changing Landscape of Biosimilars: Innovations and Continued Challenges

In the Cardinal Health 2023 Biosimilars Report, over 350 providers spanning rheumatology, ophthalmology, dermatology, and gastroenterology subspecialties were surveyed to cultivate a better understanding of the industry and the market shift that will occur with the expansion of biosimilars, including the launch of up to 10 adalimumab biosimilars in 2023. Currently, there are 40 FDA-approved biosimilar products, including 4 interchangeable options.

“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,” Debbie Weitzman, CEO, Pharmaceutical Segment at Cardinal Health, said in a statement.

The Inflation Reduction Act (IRA), signed into law on August 16, 2022, highlighted both direct and indirect impacts to the growing biosimilars market. These included changes to reimbursement add-on rates in Medicare Part B, designed to encourage physicians to prescribe biosimilars by paying them an additional 2 percentage point increase or Average Sales Price (ASP) + 8% for certain biosimilars.

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The clinician experience across specialties is crucial as the biosimilars market in the United States continues to expand. According to the survey, 76% of rheumatologists reported being “very familiar” with biosimilars and 62% felt “very comfortable” prescribing them to their patients. However, only 54% of rheumatologists surveyed agreed that biosimilars would have a positive influence on care. Further, only 18% believed that the current economic benefits of biosimilars are beneficial enough to encourage switching from a reference product. This, coupled with efficacy concerns and evaluating when to make the switch, are the primary barriers to biosimilar uptake in this subspecialty.

The first biosimilar in ophthalmology, ranibizumab-nuna, was officially launched in July 2022, followed by ranibizumab-eqrn in October 2022. Ranibizumab-nuna was able to provide a 40% discount compared to the reference drug. Most (84%) of ophthalmologists surveyed believed that introducing biosimilars will keep drug costs down and 31% noted that it could expand drug options. However, payer coverage, discomfort from a clinical standpoint, and administrative barriers were reported as the main issues ophthalmologists are most concerned about regarding biosimilar acceptance.

“Previous negative or unexpected experiences with newer retina products in the past decade have left many in the profession leery of change,” Arghavan Almony, MD, Partner and Vice President of Carolina Eye Associates, said in a statement. “We see this hesitation in the survey data which shows that although 67% of physicians felt that the FDA approval process for biosimilars is sufficient to evaluate efficacy and safety, only 48% stated that they would prescribe biosimilars themselves.”

Conversely, all gastroenterologists surveyed were at least somewhat comfortable with prescribing biosimilars to their patients and 61% believed biosimilars will have a positive impact on care. Moreover, 84% agreed or strongly agreed that patient education stressing the safety and efficacy of biosimilars is essential. Of physicians surveyed, 79% were at least somewhat comfortable switching between biosimilars.

Dermatologists were similarly comfortable with the introduction and expansion of the biosimilars market, with 80% noting that they were at least somewhat comfortable with prescribing biosimilars to their patients and 75% reporting feeling comfortable prescribing an adalimumab biosimilar. Further, approximately 3 out of 4 dermatologists were at least somewhat comfortable with discussing biosimilar options with their patients and most (82%) stressed the importance of patient education regarding safety and efficacy.

Ultimately, across all industries, experts expressed concerns regarding safety and efficacy, as well as the reality of cost effectiveness, in this growing market. However, many remain optimistic that the continued introduction of biosimilars will change the treatment landscape in a useful way, create new treatment options for their patients, and advance care.

“While much has changed, the continued need for multi-stakeholder education, awareness and dedicated research remains even more important as we expand into newer therapeutic areas and classes of trade,” experts at Cardinal Health noted in the survey. “Biosimilars continue to hold significant promise to positively impact patient care for millions in the United States and globally.”