Biosimilars Policy Roundup: April 2025

Between congressional hearings and executive orders, experts had plenty to draw on when dissecting the barriers to biosimilar access at Festival of Biologics USA to close out April 2025.

Biosimilar Actions for the Trump Administration and Congress

A recent congressional hearing on lowering health care costs highlighted biosimilars as a critical solution to the nation’s $4.5 trillion annual health care spending, largely driven by chronic diseases.¹ Lawmakers and expert witnesses emphasized the $23.6 billion in savings biosimilars have generated since 2015 while identifying key barriers to their wider adoption—such as restrictive pharmacy benefit management practices, inadequate reimbursement, and limited awareness.

Testimony called for reforms to streamline approvals, improve provider and patient education, curb anticompetitive contracting, and align policy with the biosimilar development timeline. Experts stressed that without action, the US risks missing opportunities to expand access, lower costs, and improve outcomes for millions of patients.

In a continued effort to reduce drug prices in the US, President Donald Trump signed an executive order directing federal agencies to develop actionable strategies to lower costs, with a strong emphasis on expanding access to biosimilars.² The order outlined 13 directives aimed at improving Medicare price negotiations, accelerating FDA approvals for generics and biosimilars, enhancing supply chain transparency, and curbing anticompetitive practices. It highlighted the potential of biosimilars to generate significant savings, noting that they currently account for $56 billion in savings with much more possible. The Biosimilars Forum praised the order as a meaningful step toward science-based, efficient biosimilar development.

Building on evidence that state laws influence biosimilar adoption, a recent study found that states with less restrictive substitution policies experienced significantly higher uptake of interchangeable insulin glargine-yfgn (Semglee).³ Using pharmacy claims data from over 487,000 prescriptions, researchers showed that notification requirements—such as needing to inform providers or patients about substitutions—were strongly associated with reduced biosimilar use. The findings underscored how state-level regulations can act as key barriers to biosimilar access and market penetration, even when the FDA deems a product interchangeable.

Festival of Biologics Insights and Recommendations

At the 2025 Festival of Biologics USA, speakers highlighted the evolving maturity and impact of the US biosimilars market, with Dracey Poore, MS, of Cardinal Health, emphasizing both achievements and future challenges.⁴

Poore noted the shift from early education about biosimilar approval to broader discussions on sustainability and viability, underscoring continued education needs, especially in areas like retina care, where uptake is high, but awareness remains low. In oncology, successful adoption hinges on navigating reimbursement challenges through strong payer relationships and efficient pharmacy coordination. Poore stressed that despite progress, biosimilars like adalimumab still fall short of market share expectations, pointing to the need for further clarity on interchangeability, policy alignment, and pipeline development.

In addition to Poore’s insights on the past decade’s biosimilar progress and future sustainability, other sessions at the 2025 Festival of Biologics USA reinforced the need for strategic action to unlock the full potential of biosimilars.

Sophia Humphreys, PharmD, MHA, BCBBS, from Providence, emphasized that despite the $234 billion opportunity tied to 118 biologics losing exclusivity in the next decade, biosimilar development is constrained by high research and development costs, complex regulatory hurdles, and payer-driven market barriers—particularly within specialty pharmacy.⁵ She advocated for legislative reform, formulary innovation, and expansion into underserved therapeutic classes to drive adoption and affordability.

Complementing this, Sonia Oskouei, PharmD, from Sandoz, called for bold regulatory and reimbursement reforms to overcome systemic challenges such as patent abuse, misaligned incentives, and outdated development pathways.⁶ She stressed that while the current “biosimilar void” reflects underrealized opportunity, it is not insurmountable; policy action and stakeholder collaboration are key to creating a more sustainable, competitive, and equitable biosimilar market.

Two other sessions highlighted crucial issues in drug access and biosimilar development. Christopher T. Robertson, JD, PhD, emphasized the importance of rigorous clinical trials and ethical considerations for preapproval drug access.⁷ He advocated for a "proof-before-profit" approach, discussing historical cases like laetrile, which highlighted the risks of unproven treatments. Robertson also examined the expanded access program and the Right to Try Act, noting challenges in balancing patient access with safety and informed consent.

Lastly, a panel of industry leaders discussed the challenges and strategies for biosimilar success.⁸ They stressed the need for flexible development strategies, strategic global partnerships, and careful balancing between competitive pricing and innovation. They also addressed regulatory hurdles and the impact of policies like the Inflation Reduction Act, emphasizing the need for a sustainable market model that supports both affordability and long-term growth.

References

1. Jeremias S. Experts pressure congress to remove roadblocks for biosimilars. The Center for Biosimilars^®. April 12, 2025. Accessed April 30, 2025. https://www.centerforbiosimilars.com/view/experts-pressure-congress-to-remove-roadblocks-for-biosimilars

2. Jeremias S. President Trump signs executive order to bring down drug prices. The Center for Biosimilars. April 16, 2025. Accessed April 30, 2025. https://www.centerforbiosimilars.com/view/president-trump-signs-executive-order-to-bring-down-drug-prices

3. Jeremias S. How state substitution laws shape insulin biosimilar adoption. The Center for Biosimilars. April 15, 2025. Accessed April 30, 2025. https://www.centerforbiosimilars.com/view/how-state-substitution-laws-shape-insulin-biosimilar-adoption

4. Santoro C. Decade of biosimilars yields $36 billion in savings and strengthens supply chain. The Center for Biosimilars. April 24, 2025. Accessed April 30, 2025. https://www.centerforbiosimilars.com/view/decade-of-biosimilars-yields-36-billion-in-savings-and-strengthens-supply-chain

5. Santoro C. Unlocking biosimilar potential in specialty pharmacies with legislative support, formulary changes. The Center for Biosimilars. April 24, 2025. Accessed April 30, 2025. https://www.centerforbiosimilars.com/view/unlocking-biosimilar-potential-in-specialty-pharmacies-with-legislative-support-formulary-changes

6. Santoro C. Addressing patent abuse, reimbursement models key to sustainable biosimilar market. The Center for Biosimilars. April 25, 2025. Accessed April 30, 2025. https://www.centerforbiosimilars.com/view/addressing-patent-abuse-reimbursement-models-key-to-sustainable-biosimilar-market

7. Santoro C. FDA's expanded access: from laetrile to right to try, ethical debates over early drug access. The Center for Biosimilars. April 28, 2025. Accessed April 30, 2025. https://www.centerforbiosimilars.com/view/fda-s-expanded-access-from-laetrile-to-right-to-try-ethical-debates-over-early-drug-access

8. Jeremias S. Biosimilar market development requires strategic flexibility and global partnerships. The Center for Biosimilars. April 29, 2025. Accessed April 30, 2025. https://www.centerforbiosimilars.com/view/biosimilar-market-development-requires-strategic-flexibility-and-global-partnerships