The US FDA Issues Final Guidance on Interchangeable Biosimilars

The US FDA Issues Final Guidance on Interchangeable Biosimilars

Shots:

  • The US FDA finalizes its guidance on interchangeability of a biosimilar with its reference biologic, which means it may be substituted without prescriber intervening
  • The final guidance provides clarity to the developers that the proposed biological product should meet the interchangeability standard under the Public Health Service Act (PHS Act)
  • Till date, the US FDA has licensed 19 Biosimilars as a part of Biosimilars Action Plan, targeted for patients’ access to lower-cost options

Click here to read full press release/ article | Ref: US FDA | Image: Wall Street Journal