The US FDA Issues Final Guidance on Interchangeable Biosimilars

 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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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