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BioWorld - Tuesday, December 16, 2025
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» BsUFA II tradeoffs could delay some biosimilar guidances
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BsUFA II tradeoffs could delay some biosimilar guidances
Sep. 20, 2016
By
Mari Serebrov
FDA commitments in the BsUFA II goals letter to improve communication, transparency and staffing are getting high marks from industry, which sees those steps as essential to bettering the review of biosimilars for the U.S. market.
BioWorld