Interchangeability, Meetings And Access Among BsUFA III Priorities
Stakeholders Offer Specific Recommendations On US Biosimilar User Fee Program
Industry stakeholders have offered their views on key priorities for the BsUFA biosimilars user-fee program ahead of its reauthorization.
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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.
Viatris and partner Biocon have seen FDA action on their application for a bevacizumab biosimilar rival to Avastin delayed by the need for a facility inspection, the timing of which is uncertain due to coronavirus-related restrictions.
The FDA has opened registration for a public meeting on reauthorizing the Biosimilar User Fee Act, for fiscal years 2023 through 2027.