Former FDA commissioner Janet Woodcock to headline AAM’s GRx+Biosims conference

AAM’s GRx+Biosims conference will feature guest speaker Janet Woodcock, former principle deputy commissioner of the Food and Drug Administration. The conference takes place in Rockland, Md., Oct. 21-23.

The session, hosted by Women in Health Policy, will dive into Dr. Woodcock’s contributions to the generic and biosimilars industry and her legacy within the FDA. The  discussion will focus on her leadership, achievements and the lasting impact of her work on drug regulation and accessibility.

Among the panels and education tracks to be held is a panel on interchangeability, moderated by Jessica Greenbaum, director of regulatory affairs policy U.S. at Sandoz, will discuss the importance and why now is the time to move away from a dual designation system of biosimilar and interchangeable. 

AAM noted that interchangeability can only apply to products that have been approved as a biosimilar. BPCIA requires that approved biosimilars demonstrate their “interchangeability” by way of a switching study between test and reference product. It is only after achieving an approved interchangeable status can a biosimilar then be substituted for a reference product. However, an interchangeability designation does not change or affect the safety, efficacy, and/or quality of a biosimilar licensed by the agency. Having two separate designations of biosimilar and interchangeable causes confusion among healthcare practitioners and patients, adding to the challenges of biosimilar adoption.

[Read more: A new environment for biosimilars]

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