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Biosimilars Bodies Urge Communication Enhancements For BsUFA III

Also Recommend New Approaches To Inspections And Clarity Over Interchangeability

Executive Summary

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. 

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