1. Pink Sheet

US FDA Forced To Rip Up, Start Biosimilar First Interchangeable Exclusivity Guidance Again

 
• By Derrick Gingery

New legal issues in the biosimilar space continue to slow guidance development as industry pushes for more agency transparency on its thinking.

New fact patterns forced the FDA to restart first interchangeable biosimilar exclusivity guidance development. (Shutterstock)
Key Takeaways
  • Uncertainty about first interchangeable biosimilar exclusivity remains a concern for industry.

The changing biosimilar landscape appears to be delaying US Food and Drug Administration policies that ideally would help boost the...

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