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The US FDA Released Draft Guidelines for Proposed Biosimilar or Proposed Interchangeable Biosimilars

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The US FDA Released Draft Guidelines for Proposed Biosimilar or Proposed Interchangeable Biosimilars

  • The submission of the application and labelling for proposed biosimilar or proposed interchangeable biosimilar for fewer than all the reference product’s licensed condition of use
  • The submission of supplement to an application for a biosimilar or proposed interchangeable product was licensed for fewer than all the reference products
  • Timing for the submission of a 351(k) BLA or supplement to a licensed 351(k) BLA for obtaining licensure for biosimilar or interchangeable for an indication post the expiration of any relevant exclusivity or patents

Click here to read full press release/ article | Ref: The US FDA | Image: Signbox


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This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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