Demand for biologics is growing fast, but even after Congress passed authorizing legislation in 2010, the pace of generic entry appears to have stalled. Seeking to spur increased generic competition, the FTC held an all-day workshop earlier this week to discuss evolving FDA and state regulations, especially on the key issues of substitutability and naming rules for follow-on biologics. While the workshop participants did not reach consensus, the debate was lively and provided much for the FTC to consider as it continues to examine and weigh in on the topic.
FTC Returns to the Follow-on Biologics Debate -
Nearly five years have passed since the FTC issued its 2009 report on the potential for increased competition in the “follow-on” biologics marketplace. Since that time, Congress has passed a key piece of enabling legislation, the 2010 Biologics Price Competition and Innovation Act (BPCIA), which incorporates many of the FTC’s recommendations. The BPCIA is an attempt to create a viable marketplace for generic or “follow-on” biologic drugs, akin to the one created for traditional small-molecule generic drugs by the Hatch-Waxman Act of 1984. The BPCIA authorizes the FDA to create a “fast track” for approving follow-on biologics as either “interchangeable” (identical in effect to the reference drug) or “biosimilar” (“highly similar” to the reference drug, with “no clinically meaningful differences [in] safety, purity, and potency”).
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