Unlocking the Full Potential of Biosimilars

Last week, the House Ways and Means Health Subcommittee held a hearing to discuss current health and future of the American biosimilars market, with expert testimony from Arnold Ventures grantee, Dr. Aaron S. Kesselheim, M.D., J.D., M.P.H. of Harvard's Program on Regulation, Therapeutics, and Law (PORTAL) . 

Biologics, which are large-molecule drugs like the cancer drug Keytruda, are developed through biological processes and face less competition compared to small-molecule drugs like Lipitor, a statin, which are chemically synthesized. The Food and Drug Administration’s ( FDA ) biosimilar approval pathway, established through the Affordable Care Act (ACA) in 2010, was intended to create lower-cost, biosimilar competitors for biologics similar to how the Hatch-Waxman Act ushered in the robust generic drug market we see in the U.S. today.   Unfortunately, the full potential of biosimilars has yet to be fully realized.

In his recent testimony, Dr. Kesselheim highlighted several policy solutions that would encourage greater uptake and development of biosimilars.  One such solution is enhancing biosimilar interchangeability with reference products.  This would boost uptake and increase savings.  Unlike with small-molecule generics, biosimilars must be specifically requested by the prescriber unless they are designated as “interchangeable” biosimilar by FDA.

The FDA’s stance on this “interchangeability” designation has been evolving over time.  In June 2024, FDA released updated draft guidance that removes the requirement of additional clinical trials to demonstrate interchangeability. We recommend that Congress codify this guidance, while still allowing the FDA flexibility to require these trials when necessary.

At the state level, substitution laws should provide maximum ability for pharmacists to substitute the lowest cost biologic for patients.

By enacting these policies, we can further unlock the potential for biosimilars to lower costs and improve patient care.

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