This report identifies upcoming biologic patent expirations that may not attract biosimilar competition, creating a “biosimilar void.” It examines factors such as limited market size, molecule complexity, orphan indications, and pricing dynamics that reduce development incentives. The analysis highlights risks to affordability and access if competition fails to materialize. The report outlines policy, regulatory, and market-based solutions—including streamlined development pathways and incentive alignment—to encourage biosimilar entry where competition is economically viable.

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