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GUIDANCE DOCUMENT

Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry Draft Guidance for Industry February 2020

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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-2019-D-5270


Docket Number:
FDA-2019-D-5270
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research
Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research

This guidance provides recommendations to applicants seeking licensure under section 351(k) of the Public Health Service (PHS) Act of a proposed biosimilar or proposed interchangeable biosimilar for fewer than all of the reference product’s licensed conditions of use. This guidance also provides recommendations on the submission of a supplement to a licensed 351(k) biologics license application (BLA) seeking to add a condition of use that previously has been licensed for the reference product to the labeling of a licensed biosimilar or interchangeable product, including considerations related to the timing of such submissions.