Assessing the Biosimilar Void in the U.S.

32 Pages

This report analyzes upcoming biologic patent expiries and identifies gaps where biosimilar competition may not emerge, creating a “biosimilar void.” It examines factors limiting biosimilar development, including market size, molecule complexity, orphan status, and timing of exclusivity loss. The findings highlight risks to affordability and access if competition fails to materialize. The report outlines policy and market-based solutions to encourage sustainable biosimilar development and competition.

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