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