FDA issues draft guidance on licensing biosimilars for fewer indications

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The US Food and Drug Administration (FDA) announced in February 2020 that it had issued draft guidance on getting approval for biosimilars for just some of the approved indications of the originator biological.

Guidance V13F21

In the draft guidance, which was published in the Federal Register on 7 February 2020, FDA outlines its recommendations to biosimilar makers looking for marketing approval for a proposed biosimilar for fewer than all of the reference product’s licensed conditions of use.

Biosimilars and interchangeable biosimilars: licensure for fewer than all conditions of use for which the reference product has been licensed
Date: February 2020

FDA addresses the following issues in the draft guidance:
• Submission of an application for a biosimilar or proposed interchangeable product for fewer than all of the reference product’s licensed conditions of use
• Development of draft labelling
• Timing considerations for submission

With respect to the issue of timing, the draft guidance addresses the situation in which an applicant may want to go down this route to avoid the risk of patent infringement, but may later wish to submit a supplement for further indications. For the same reason applicants may also request that the FDA does not take action on their application or supplement before a specified date.

FDA has released the draft for a comment period of two months, i.e. until 7 April 2020. Comments on the draft guidance can be posted to the Division of Dockets Management (DDM) under Docket FDA-2019-D-5270. This can be done via the website www.regulations.gov or written comments can be mailed to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852, USA.

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Source: Federal Register, US FDA

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