This post was written by Jennifer Pike.
A new draft guidance document on formal meetings between the FDA and biosimilar biological sponsors is now available from FDA. The draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products. Further, the draft guidance assists sponsors and applicants in generating and submitting meeting requests and the associated meeting package to FDA. The draft guidance provides good meeting management practices that are intended to provide consistent procedures that will promote well-managed meetings and ensure that such meetings are scheduled within a reasonable time, conducted efficiently, and documented appropriately. The following five meeting types are described in the draft guidance: (1) Biosimilar Initial Advisory meeting (initial assessment of whether licensure is feasible for product, and if so, general advice on development of product); (2) biosimilar biological product development (BPD) Type 1 meeting (meeting that is necessary for an otherwise stalled BPD program to proceed); (3) BPD Type 2 meeting (meeting to discuss a specific issue or questions where FDA will provide targeted advice); (4) BPD Type 3 meeting (in-depth data review and advice regarding on-going BPD program); and (5) BPD Type 4 meeting (meeting to discuss format and content of application). Comments on the draft guidance should be submitted in writing, or electronically at www.regulations.gov, by May 31, 2013.