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EMA Re-Examines Decisions On Prestige’s Trastuzumab And Synchron Studies

CHMP Rejection Of Herceptin Biosimilar And Suspension Of Generics To Be Reviewed

Executive Summary

Following decisions by the EMA’s CHMP to deny Prestige Biopharma a marketing authorization for its trastuzumab biosimilar and to suspend the marketing authorizations of dozens of generics due to concerns over bioequivalence tests, the European regulator has confirmed it will review the opinions.

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