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FDA Offers Clarity On Biosimilar Interchangeability

Guidance Provides Draft Q&As On Applications And Labeling

 
• By Dave Wallace

A draft guidance document opened for comment by the FDA offers additional Q&As on issues around biosimilar applications and interchangeability.

FDA entrance sign 2016
The FDA has published further draft Q&As on biosimilars • Source: Shutterstock

Draft guidance in the form of additional Q&As on biosimilar applications and issues around interchangeability has been opened for comment until 19 January 2021 by the US Food and Drug Administration. The document provides questions and answers that build on existing Q&A guidelines on the topic.

On the question of how applicants should seek FDA review for biosimilars that they wish to be deemed interchangeable, the guidance states that if a biologics license application submitted under the section 351(k) biosimilars pathway is intended to support licensure as an

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