FDA finalizes guidance for biosimilars meetings

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FDA finalizes guidance for biosimilars meetings

INICIO/Directrices | Posted 29/01/2016 0 Post your comment

The US Food and Drug Administration (FDA) announced on 18 November 2015 that it had finalized its guidance for industry on formal meetings between the FDA and biosimilars sponsors.

The guidance, which outlines standardized procedures for requesting, preparing, scheduling, conducting and documenting such formal meetings with FDA, was first released as a draft back in April 2013 [1]. The finalized guidance does not differ significantly from that initial draft, outlining five types of meetings that a biosimilars applicant can request from the FDA.

Formal meetings between the FDA and biosimilar biological product sponsors or applicants
Date: November 2015
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm345649.pdf

The meetings included in the guidance are the following:

Biosimilar Initial Advisory meeting:
This type of meeting is an initial assessment limited to a general discussion regarding whether licensure via the biosimilars pathway may be feasible for a particular product and giving general advice on the expected content of the development programme. This meeting type does not include substantive review of summary data or full study reports.

BPD Type 1 meeting:
A Biosimilar Biological Product Development (BPD) Type 1 meeting is a meeting that is necessary for an otherwise stalled BPD programme to proceed.

BPD Type 2 meeting:
A BPD Type 2 meeting is a meeting to discuss a specific issue, e.g. proposed study design or endpoints, or questions where the FDA will provide targeted advice regarding an ongoing BPD programme. This can include substantive review of summary data, but does not include review of full study reports.

BPD Type 3 meeting:
A BPD Type 3 meeting is an in-depth data review and advice meeting regarding an ongoing BPD programme. This includes substantive review of full study reports or an extensive data package, e.g. detailed and robust analytical similarity data, FDA advice regarding the similarity between the proposed biosimilar and the reference product based on a comprehensive data package, and FDA advice regarding the need for additional studies, including design and analysis, based on a comprehensive data package.

BPD Type 4 meeting:
A BPD Type 4 meeting is a meeting to discuss the format and content of a biosimilar biological product application or supplement to be submitted via the abbreviated biosimilars pathway. Although the proposed content of the application will be discussed, this does not include substantive review of summary data or full study reports.

The guidance provides FDA’s current thinking on the topic and discusses the principles of good meeting management practices (GMMPs).

Related article
US guidelines for biosimilars

Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance for biosimilar meetings [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 29]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-for-biosimilar-meetings

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Source: Federal Register, US FDA