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FDA Moves to Streamline Biosimilar Development: Implications for Regulatory Strategy and Clinical Study Design
The Food and Drug Administration (FDA) has issued new draft guidance signaling a policy shift toward reducing the need for comparative efficacy (CES) studies in biosimilar applications. The FDA’s approach aims to accelerate biosimilar development timelines, lower costs, and increase competition for biologics….
By: Wilson Sonsini Goodrich & Rosati