New FDA Guidance on meetings with Biosimilar Companies

Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants: Guidance for Industry

This guidance provides recommendations to industry on formal meetings between the Food and Drug Administration (FDA) and biosimilar biological product sponsors or applicants.

The FDA has committed to meeting certain performance goals set forth in a letter from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives.4 The performance goals include meeting management goals for formal meetings that occur between the FDA and sponsors or applicants during the development phase of a biosimilar biological product. The FDA encourages sponsors and applicants to use the meetings described in this guidance to optimize product development and facilitate submission of marketing applications.

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