USA – Groups seek clarity on interchangeability in BsUFA III

Industry groups and biosimilar manufacturers are seeking explicit guidance from the US Food and Drug Administration (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. (RELATED: FDA, Industry set priorities for BsUFA III, Regulatory Focus 19 November 2020).
“While FDA has published several guidance documents related to biosimilars, industry continues to struggle with the lack of clarity regarding the Agency’s policy on certain aspects of interchangeability as well as regulatory expectations for certain post-approval changes for biosimilar or interchangeable products,” Andrea Maresca wrote on behalf of the Biosimilars Forum…