FDA proposes regulations for meetings between agency, biosimilar makers

Agency releases draft guidance, calls for comment

SILVER SPRING, Md. — The Food and Drug Administration is seeking comment from drug makers and others concerning formal meetings between the agency and companies looking to market follow-on biologics.

The agency's Center for Drug Evaluation and Research announced Friday the release of draft guidance titled "Guidance for Industry: Formal Meetings Between the FDA and Biosimilar Biologic Product Sponsors or Applicants." The agency said the purpose of the guidance was for comment purposes only, and it did not reflect current regulations. An abbreviated approval pathway for follow-on biologics was enacted as part of the Patient Protection and Affordable Care Act of 2010, but regulations have yet to be finalized.

The FDA said the regulations were needed to ensure efficient, consistent procedures for meetings between the agency and drug makers, whether they take place face to face, via teleconference or video conference.

The draft guidance proposes five different types of meetings: Biosimilar Initial Advisory meetings, which discuss the feasibility of a proposed product; Biologic Product Development Type 1 meetings, to discuss issues like clinical holds, special protocols and safety issues; BPD Type 2 meetings, to discuss specific issues such as proposed study designs or study endpoints; BPD Type 3 meetings, which are in-depth data review and advice meetings; and BPD Type 4 meetings, to discuss the format and content of a product application.


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