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The US FDA Issues Final Guidance on Interchangeable Biosimilars

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The US FDA Issues Final Guidance on Interchangeable Biosimilars

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  • 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

Click here to­ read the full press release 

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This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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