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CSRO Leadership Gives Testimony at FDA/FTC Biosimilar Workshop
Posted: March 25, 2020
Dr. Madelaine Feldman
Dr. Gregory Schimizzi
On March 9, 2020, the Federal Trade Commission and the Food and Drug Administration co-sponsored a public workshop focusing on promoting competition in biologics markets. The workshop was held at the FDA’s White Oak Campus in Silver Spring, Maryland and was also viewable via webcast.
Workshop panelists discussed the agencies’ efforts to support competition between biosimilars and reference biologics, to discourage false or misleading statements about biosimilars’ safety and efficacy, and to deter anticompetitive behaviors in the biologic marketplace. Last month, the two agencies also signed a joint statement promoting competition in markets for biologics.
At the workshop, CSRO President, Dr. Madelaine Feldman and Former CSRO President, Dr. Gregory Schimizzi were each given an opportunity to deliver testimony. The CSRO leaders provided the agency with the perspective of the practicing rheumatologist. Urging caution, they advised the agencies to require some clinical data for all incoming indications, especially when the pathophysiologic mechanisms involved in the diseases are clearly different. Furthermore, their testimony also gave support for standardized immunogenicity testing of biosimilar agents across all disease conditions as well as control subjects.
CSRO would like to thank the Federal Trade Commission and the Food and Drug Administration once again for hosting the workshop. It was a great privilege to offer testimony on such an important issue. Through workshops like this, a safer and more cost-efficient healthcare system can be developed.