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Henlius Has First ‘China-Developed’ Biosimilar Accepted For EMA Review

 
• By Penelope MacRae

European regulators have accepted for review a marketing authorization application for the first ‘China-developed’ biosimilar, a version of Roche’s blockbuster breast-cancer drug Herceptin (trastuzumab) developed by Chinese biotech firm Henlius.

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Henlius is boasting the first China-developed biosimilar to be accepted for review by the EMA • Source: Shutterstock

Marking a major first step toward the opening of global markets for made-in-China biosimilars, Shanghai Henlius Biotech has announced that the European Medicines Agency has accepted for review an application for marketing its HLX02 trastuzumab biosimilar version of Roche’s breast-cancer drug Herceptin.

It is the first time the EMA has accepted a marketing authorization application for a “China-developed” biosimilar

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