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

 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

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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