The Reagan-Udall Foundation for the FDA, in collaboration with the FDA's Center for Drug Evaluation and Research (CDER), hosted a series of closed-door virtual roundtable discussions with developers of biosimilar biologic products (biosimilars). This report outlines the key themes and possible research priorities discussed during the sessions, which CDER can consider alongside input from other stakeholder engagement efforts as it considers next steps for the BsUFA III Regulatory Science Pilot Program. This report is not intended to convey official US FDA policy.

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BsUFA Report