FDA Publishes BsUFA III Commitment Letter Ahead Of 2022 Renewal
Biosimilar Supplement Review Goals Aim To Speed Approvals
Following months of negotiations with industry and stakeholders, the FDA has released the commitment letter for the third iteration of its five-year Biosimilar User Fee Amendments program, marking another step ahead of its reauthorization.
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OTBB head Sarah Yim says FDA internal thinking is not aligned on the idea and that a lot of convincing was necessary to drop the clinical study requirement for insulin biosimilars.
US FDA research funded under BSUFA III will investigate what kind of safety data is needed for interchangeability. A demonstration project aimed at improving biosimilar product development efficiency and enhanced regulatory decision-making also will be part of the new regulatory science research program.
Post-warning letter meetings for manufacturing issues and updates to the complex product meeting process are included in the user fee extension agreement.