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.
'Authorized Biosimilars' Cannot Use 351(k) Pathway
FDA Concludes Reference Product Must Be Another Biological Product
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 draft 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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