Groups seek clarity on interchangeability in BsUFA III
Groups seek clarity on interchangeability in BsUFA IIIIndustry groups and biosimilar manufacturers are seeking explicit guidance from the FDA on interchangeable biosimilar products. The comments were made to the agency as part of the reauthorization process for Biosimilar User Fee Act (BsUFA III) program.
The recommendations for improvements in the third iteration of FDA’s biosimilars review program were made as part of a public docket opened by FDA. The agency also recently held a public meeting to kick off the reauthorization process for BsUFA III, which will begin in FY 2023 and run through FY 2027.
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