FDA pressing on with pilot to advance biosimilar development

26 January 2023

The US Food and Drug Administration (FDA) has released the BsUFA III Regulatory Science Pilot Program: Research Roadmap.

This roadmap provides additional information about the biosimilar regulatory science research pilot program and is accompanied by a public docket to gather feedback.

The Biosimilar User Fee Amendments (BsUFA) promote the development of safe and effective biosimilars by supporting the FDA review of submissions.

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