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'Authorized Biosimilars' Can't Use 351(k) Pathway, US FDA Concludes

 
• By Sue Sutter

FDA's position will impact what types of biosimilar and interchangeability applications can be submitted for insulin and other "deemed" protein products. Agency says in final Q&A guidance on transition provisions that the holder of a standalone BLA cannot reference its own product in an application for a bisoimilar or interchangeable version.

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US FDA is finalizing preparations for the regulatory transition that will take place on 23 March. • Source: Shutterstock

Less than three weeks before the regulatory transition of certain protein products to biologics, the US Food and Drug Administration is clarifying what types of biosimilar and interchangeability applications will and will not be permitted in the highly competitive insulin space after 23 March.

In a question-and-answer final guidance on the Biologics Price Competition and Innovation Act’s “deemed to be a license” provisions, the agency said the holder of a standalone biologics license...

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