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Senators to Receive Update on Biosimilar Implementation from CDER’s Woodcock

Today, members of the Senate Health, Education, Labor & Pensions (HELP) Committee will have an opportunity to hear from and question Dr. Janet Woodock, the director of FDA’s Center for Drug Evaluation and Research (CDER), regarding the agency’s implementation of the new approval pathway for biosimilar products created under the BPCIA.  Dr. Woodcock is listed as the only person who will be presenting to the HELP Committee.

The hearing, which will be webcast, is billed as a “progress report from FDA,” and could yield new information about the expected timeline for FDA’s initial thoughts about how a biosimilar sponsor could demonstrate the interchangeability of its product with the relevant reference biological product.   A long-anticipated draft guidance on interchangeability is listed among the agency’s plans for 2015, but a more precise release date has not been forthcoming.  Industry is also eagerly awaiting initial guidance on the labeling of approved biosimilars.  Last month, FDA released the first draft guidance on another complex issue that stems from real-world implementation of the biosimilar approval pathway – the question of what nonproprietary names should be assigned to those products, which may or may not be interchangeable with the reference biologic and which may be approved for only a subset of the reference product’s labeled indications.  Naming, labeling, and of course interchangeability are critical drivers for development of the nascent U.S. biosimilars market, and each of these issues (and others) garner significant scientific, public health, and drug pricing-related comments from stakeholders with very different interests.  It will not be surprising if Dr. Woodcock receives similarly disparate and conflicting comments and pressures today from HELP Committee Senators.



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Joanne counsels global clients on the regulatory and distribution-related implications when bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized.