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GUIDANCE DOCUMENT

New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2) New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).” December 2018

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2011-D-0611
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).” The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA's interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This draft guidance document revises the draft guidance document entitled “Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009,” issued May 13, 2015, to provide new and revised Q&As.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-D-0611.