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Biosimilars Bodies Urge Communication Enhancements For BsUFA III

Also Recommend New Approaches To Inspections And Clarity Over Interchangeability

 
• By Akriti Seth

Biosimilars industry stakeholders have suggested ways to enhance communication and improve the US regulatory pathway for biosimilars, as they weighed in on an interim assessment of the program for enhanced review transparency and communication in the Biosimilar User Fee Act II, ahead of the upcoming reauthorization of BsUFA for fiscal years 2023 through 2027 by the FDA. 

Conference
Industry bodies work together to improve biosimilars regulatory pathway • Source: Shutterstock

Calling communication one of the “cornerstones of success” of the Biosimilar User Fee Act, the Biosimilars Forum industry body has suggested that enhancing interactive communications from the US Food and Drug Administration around meetings and information requests would contribute to the further success of the BsUFA program.

After the FDA shared results of an external review of the agency’s program for enhanced review transparency and communication for 351(k) Biologics License Applications in January 2021, industry bodies such as the Biosimilars Forum, the Association for Accessible Medicines’ Biosimilars Council and originator body the Pharmaceutical Research and Manufacturers of America have

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