by Amanda Conschafter, blog editor
The Senate Subcommittee on Primary Health and Retirement Security’s September 17 hearing featuring FDA Director Janet Woodcock, MD, resulted in a packed hearing room—and hopes that FDA guidance on unresolved policy issues affecting biosimilars will materialize sooner rather than later.
- Transparent labeling for biosimilars
- Distinct names for biosimilars and biological reference products
- Rules of substitution for biosimilars deemed interchangeable with their reference biologic.
Dr. Woodcock did not provide a specific timeframe for final FDA guidance on these issues but acknowledged that it was forthcoming. She also noted that the FDA encourages feedback on its recent biosimilar naming guidance.
Senators pointed out that the FDA lags behind Europe in formulating such policies, to which Dr. Woodcock responded that the United States had been six years behind Europe in establishing a regulatory approval pathway for biosimilars. She also reiterated the FDA’s participation with the World Health Organization’s International Nonproprietary Names Committee and acknowledged the benefits of a global naming convention.
Senate committee members stressed to Dr. Woodcock one point in particular: A strong market for biosimilars requires physician and patient confidence in the products. As senators’ questioning indicated, fostering confidence will require educating patients and clinicians about biological and biosimilar medications. It will also require clear, comprehensive and timely FDA guidance on how these medications will be regulated.