Henlius and Accord Announce EMA Recommendation for Marketing of Their Trastuzumab Biosimilar

We previously reported on Shanghai Henlius’s (“Henlius”) biosimilar developments, including their announcement of an exclusive license agreement with Mabxience Research, S.L. to develop and commercialize their trastuzumab biosimilar, HLX02. This week, Henlius jointly announced with Accord Healthcare Limited that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for their trastuzumab biosimilar HLX02.  Trastuzumab has been indicated for the treatment of HER2 positive early breast cancer, HER2 positive metastatic breast cancer and previously untreated HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction.

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