What is Fair for Drug Exclusivity?

Patricia Van Arnum PharmTech editorThe debate over biosimilars was ratcheted up this week as members of Congress and industry responded to a Federal Trade Commission (FTC) report that examined the impact of possible incentives to promote competition for follow-on biologics (FOB). At the heart of the debate is the length of time for data exclusivity for biopharmaceuticals, with certain key members of Congress seeking reduced times and industry seeking to maintain at least the status quo. The debate raises questions not only on how to proceed in developing a regulatory pathway for biosimilars, but also addresses the larger issue of how measures may hinder or facilitate drug innovation. Read more »

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