FDA issues draft guidance for biosimilar meetings

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FDA announced on 1 April 2013 that it had issued draft guidance for biosimilar meetings outlining standardized procedures for requesting, preparing, scheduling, conducting and documenting such formal meetings with FDA.

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The US has had a legal pathway for biosimilars in place since the approval of the Biologics Price Competition and Innovation Act, which was signed into law on 23 March 2010 by President Barack Obama, but has lacked practical guidance from FDA [1]. In contrast, Europe approved its first biosimilar back in 2006.

It is perhaps the increasing industry interest in having such meetings with FDA that has prompted the release of this fourth draft guidance by FDA for comment purposes only. The agency previously issued three draft guidance documents on biosimilar product development on 10 February 2012 [2].

This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological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 regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance assists sponsors and applicants in generating and submitting a meeting request and the associated meeting package to FDA for biosimilar biological products.

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

The draft guidance document provides FDA’s current thinking on the topic and discusses the principles of good meeting management practices (GMMPs).

What happens next?
Comments regarding this document can be submitted to http://www.regulations.gov or to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, room 1061, Rockville, MD 20852, USA. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance, i.e. 1 April 2013.

Related article

US guidelines for biosimilars


1.  GaBI Online - Generics and Biosimilars Initiative. US healthcare reform [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Apr 4]. Available from: www.gabionline.net/Policies-Legislation/US-healthcare-reform

2.  GaBI Online - Generics and Biosimilars Initiative. FDA finally issues draft biosimilar guidance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Apr 4]. Available from: www.gabionline.net/Guidelines/FDA-finally-issues-draft-biosimilar-guidance

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Source: FDA, Federal Register

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