Panelists Stress Stakeholder Education to Build Confidence in Biosimilars

The future of a sustainable biosimilars market in the US depends on strategic legislative reforms, improved education for stakeholders, and a robust reimbursement framework that together enhance accessibility, build confidence, and ensure long-term cost savings in health care, according to a panel of industry leaders.¹

With $36 billion saved in 2023 and nearly 3 billion days of patient therapy delivered without any clinically significant differences from originator biologics, biosimilars are proving their value in the health care space. The panel discussion took place at the GRx+Biosims 2024 conference and included representatives from 3 biosimilar manufacturers (Sandoz, Teva Pharmaceuticals, Biocon Biologics).

Sandoz, Teva Pharmaceuticals, and Biocon Biologics are 3 of the biggest biosimilar players in the space, each having multiple biosimilars products actively competing on the US market. The GRx+Biosims conference where this panel discussion took place was held from October 21 to October 23, 2024, in Rockville, Maryland. | Image credit: Yuliia Sihurko - stock.adobe.com

During the discussion, Sonia Oskouei, PharmD, vice president and US head of biosimilars and specialty at Sandoz, emphasized that true accessibility and sustainability in the US market will require a strategic focus on education and policy that supports patients and providers.

Oskouei, who has a decade of experience working with biosimilars, discussed the critical need for expanding biosimilars across various therapeutic areas, referencing the recent approvals for the first denosumab and aflibercept biosimilars.^2,3 She pointed to the journey from biosimilars being in niche oncology markets to mainstream use, adding that more can be done to sustain this growth by streamlining approval processes and educating the public.

Meanwhile, Mary Pietryga, vice president of global marketing at Teva Pharmaceuticals who has 3 decades of experience working in biopharmaceuticals, described the challenges in expanding biosimilar uptake. Patient and provider education gaps, she noted, continue to limit the full realization of biosimilars’ benefits, and improved awareness could accelerate adoption and cost savings.

Joshua Salsi, head of North America commercial at Biocon Biologics, emphasized that the complexity of the US health care market demands a reimbursement model that balances affordability with high-quality standards. Although interchangeability is a legal designation for biosimilars, he explained, it has not become a deciding factor for providers, who are more focused on therapeutic similarity. The discussion emphasized that clearing up misconceptions about interchangeability is essential to driving confidence in biosimilars.

The conversation also touched on legislative factors, with moderator Craig Burton, senior vice president of policy and strategic alliances for the Association for Accessible Medicines and executive director of the Biosimilars Council, discussing the impact of recent policies. Legislative reforms, the panel agreed, are key to supporting the biosimilars market, as streamlined processes can help reduce economic pressures and improve biosimilar accessibility. Oskouei highlighted that by bolstering FDA resources, legislation could enable faster evaluations and approvals, fostering a more competitive and sustainable market.

The role of pharmacy benefit managers (PBMs) emerged as a critical topic. Pietryga and Salsi outlined the challenges biosimilar companies face in navigating PBM contracts, which often favor established biologics. They noted that if the market could encourage more competition among PBMs, biosimilars would have a better chance to compete fairly. Oskouei reiterated that increasing understanding about PBMs’ role and impact could benefit all stakeholders and improve patient access.

"The reality is, especially over the last 5 years, as more [innovator] biologics and the biosimilars to those biologics are being introduced into the marketplace, the US specifically is performing as a high grip market…. Decreasing the cost and time of your resource allocation to get these molecules to market is critical. Ensuring the marketplace to launch these assets into is also critical. I think that we truly are this inflection point to ensure that the success and the adoption of biosimilars continues to have the utmost sustainability moving forward,” commented Salsi.

Lastly, the panel discussed the implications of the Inflation Reduction Act (IRA). Pietryga detailed that while the IRA’s cost-saving intentions are commendable, its effects might limit biosimilar competitiveness unless paired with sustainable reimbursement.

“You have really beneficial payers, and they're aligned to PBMs and specialty pharmacies, and they each take 1 manufacturer. So, you end up with a winner-takes-all scenario…. Ultimately, over time, you could see some players exiting the market, or starting to see some of the big players exit. The hope [in the beginning] was to have an array of manufacturers be able to create this competitive market but now it’s like we’ve gone to the other extreme,” Pietryga explained.

Salsi echoed this, stressing that policy makers should carefully consider the economic environment biosimilars require to thrive. Oskouei added that an education strategy is vital to ensuring all stakeholders—patients, providers, and policy makers—understand the value biosimilars bring.

The session concluded with a call for collaborative action. Pietryga emphasized a united industry approach to overcome market challenges. Salsi reiterated the need for a robust reimbursement model and ongoing education, while Oskouei advocated for innovation and comprehensive educational efforts to bridge gaps in understanding. With continued dedication to these goals, biosimilars are positioned to make high-quality, affordable therapies more accessible, ultimately contributing to a sustainable health care future.

Oskouei concluded with a look toward the future: “It's a ‘circle of biological life’ that biosimilars enable, so you bring healthy competition, lower costs, and ensure the accessibility of critical biologics. But equally important and equally exciting to me is reusing that biosimilar's profit to invest in the next generation of innovation. So, we can move away from supportive care to disease-modifying treatments to more curative treatments that are better than everything we have available to us today.”

References

1. Burton C, Oskouei S, Pietryga M, Salsi J. Biosimilars market leaders discussion. Presented at: GRx+Biosims; October 21-23, 2024; Rockville, MD.

2. Jeremias S. FDA approves first denosumab biosimilars. The Center for Biosimilars^®. March 5, 2024. Accessed October 31, 2024. https://www.centerforbiosimilars.com/view/fda-approves-first-denosumab-biosimilar

3. Jeremias S. FDA approves first Eylea biosimilars. The Center for Biosimilars. May 20, 2024. Accessed October 31, 2024. https://www.centerforbiosimilars.com/view/fda-approves-first-eylea-biosimilars