Biosimilars Forum Chair of Scientific Affairs Committee to Speak at the Festival of Biologics USA
Device selection for biosimilars and interchangeable biosimilars plays a major role in streamlining biosimilar development
March 24, 2025 – Hillel P. Cohen, Chair of the Scientific Affairs Committee for the Biosimilars Forum, will speak at the Festival of Biologics USA 2025 on April 24, 2025, to discuss importance of streamlining biosimilar development. Specifically, the presentation will focus on device selection for biosimilars and interchangeable biosimilars.
Because of their complexity, biosimilars involve significant research and development costs. The cost of a typical biosimilar can range from $100 million to $300 million and take six to nine years from analytical characterization to approval. By streamlining development and ensuring market competitiveness, Americans can have access to more lower-cost biosimilars.
This presentation will underscore how streamlining the development of new biosimilars is vital to lowering prescription drug prices and bringing new medicines to Americans that need them. Cohen will highlight the significance of device selection to biosimilar development and the barriers to development and regulatory approval of devices for interchangeable biosimilars.
Cohen will offer suggestions for modifying device data requirements to reflect current science as well as opportunities for increased FDA-industry communication about device selection. Above all, the safety and efficacy of biosimilars will not be impacted by these suggestions.
“Biosimilar development must become more efficient while maintaining the highest global standards for safety, quality and efficacy,” Cohen said. “Major challenges exist in the process for selecting and validating devices for biosimilars and interchangeable biosimilars. Fortunately, there are opportunities and options to address the challenges.”
Streamlined development will help address the biosimilars void facing Americans. Only 12 molecules set to lose patent protection from in the next decade have biosimilars in development, with the remaining 106 biologic patent expiries representing a biosimilar void. If all products with a patent expiring in the next 10 years were to have a biosimilar in the pipeline, the U.S. healthcare system could save an additional $189 billion in addition to savings generated by biosimilars already on the market or expected to enter.
In an ideal market, if all products facing patent expires in the next 10 years that currently have no biosimilar pipeline were to face biosimilar competition at expiry, the U.S. healthcare system could save an additional $189 billion on top of savings generated by biosimilars already on the market or expected to enter.
In 2023, the U.S. healthcare system saved $12.4 billion from biosimilars alone. This contributed to a cumulative total of $56 billion in savings from biosimilars—compared to what spending would have been without biosimilars—since 2015. Prices continue to increase for biologic drugs. These medications represented 46% of U.S. prescription drug spending in 2022, despite only making up 3% of prescriptions.
About the Festival of Biologics USA 2025
The Festival of Biologics brings together senior biologics professionals across the value chain to showcase their research, collaborate on challenges, forge new connections and ultimately advance the industry to improve patient health. Information on registration is available here.
About the Biosimilars Forum
The Biosimilars Forum work to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines and improving health care. The Biosimilars Forum will provides evidence-based information to inform and support public policies that encourage awareness, access, and adoption of biosimilars. For more information on the Biosimilars Forum’s work to increase access to lower-cost biosimilars, visit biosimilarsforum.org.