Regulatory Roundup: FDA Holds Biosimilars Public Hearing

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FDA Holds Biosimilars Public Hearing

This week, the US Food and Drug Administration held a two-day public hearing to gain public input on how to implement and regulate the follow-on biologics pathway that was cleared via President Obama’s Biologics Price Competition and Innovation Act of 2009, which falls under the 2010 approved healthcare reform legislation. Members from the agency’s biologics and drug evaluation and research centers (the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research), as well as the Office of Compliance, were on the panel. Representatives from the major industry trade associations, the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), and the Generic Pharmaceutical Association (GPhA), gave presentations, as did other members of industry and healthcare. The transcript of the hearing will be available here. See the related PharmTech Talk blog post, Biosimilars Hearing Begins Today.