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Senate Bill Proposes Slashing 'Red Tape' Around Biosimilar Interchangeability

Legislation introduced by Utah Senator Mike Lee would eliminate testing to show a biosimilar can be substituted for a reference biologic product. Lee contends the current testing requirement adds costs and delays market access for these lower-cost biological medicines. ....

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Senator Reintroduces Biosimilar Red Tape Elimination Act

Senator Mike Lee (R, Utah) reintroduced the Biosimilar Red Tape Elimination Act to Congress. The bill aims to get rid of switching study requirements for companies looking to obtain an interchangeability designation for a biosimilar. ....

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Blockbuster Biologics Review | Issue 18 | Morgan Lewis

Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment. ....

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