Policy Documents

No. 122 Safety First: A Legislator’s Brief on Biosimilars

Richard Dolinar, M.D. –
June 18, 2009

Congress is currently exploring legislation that would create a new drug approval process in the U.S. Food and Drug Administration for what are called follow-on biologics, or “biosimilar” therapies. Biologics are large, complex molecules that are genetically engineered. Follow-on biologics, or “biosimilars,” are products marketed after patents on the original biologic have expired. As their name suggests, these products are similar but not identical to the originator product they are based on.

Now that patents on older biologics are beginning to expire, Congress has turned its attention to creating an FDA approval pathway for biosimilars. Legislation introduced by Rep. Henry Waxman (H.R.1427) and Reps. Anna Eshoo, Jay Inslee, and Joseph Barton (H.R.1548) would create pathways for regulatory approval of biosimilars. These two bills take very different approaches to the task of protecting patient safety through clinical trials and preserving innovation incentives through intellectual property protection.

It’s crucial that lawmakers grasp the implications of this pending legislation for medical practitioners and for patients who have increasingly come to rely on the therapeutic benefits of biologics. Unless legislation regarding biosimilars protects the economic viability of the research and development process for new treatments and cures, the promise of emerging therapies for Alzheimer’s, multiple sclerosis, and other dread diseases will never be fulfilled.

This paper will explore the challenges facing Congress in drafting legislation that strikes a prudent balance among the goals of (1) ensuring the safety and efficacy of biosimilars, (2) preserving incentives for innovative research and development of future biologics, and (3) increasing price competition and patients’ access to biologics.

Part 2 explains what biologics are and how they differ from biosimilars and other drugs. Part 3 introduces the principles that should drive legislation establishing an FDA approval pathway for biosimilar drugs, based on the science-based consensus of physician organizations, the European Medicines Agency (EMEA), and the chief scientists of the FDA. It also highlights the challenges and concerns facing legislators as they seek to protect patient safety, increase access, and preserve innovation in future development of biosimilars. Part 4 outlines recommended reforms, and Part 5 compares and evaluates the key provisions in the two competing House bills introduced by Waxman and by Eshoo, Inslee, and Barton. Part 6 summarizes the key points in the paper and states conclusions.