Henlius and Accord Receive CHMP’s Positive Opinion for its HLX02 (biosimilar, trastuzumab)

Shots:

• The EMA’s CHMP has granted a positive opinion, recommending marketing authorization for HLX02 to treat HER2+ early breast cancer, HER2+ metastatic breast cancer & previously untreated HER2+ metastatic adenocarcinoma of the stomach or gastro-esophageal junction
• EC will now review the CHMP’s positive opinion, with the expected regulatory decision in next 2-3mos. Once approved, a centralized marketing authorization will be granted for all EU Member States, Iceland, Norway and Liechtenstein
• HLX02 is a biosimilar mAb, developed & manufactured by Henlius while it will be distributed and marketed by Accord across the EU. HLX02 shows high bio similarity in terms of quality, safety and efficacy to its reference product, Herceptin 

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