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

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

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