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
Ref: US FDA | Image: Wall Street Journal
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