EMA accepts first 'China-developed' biosimilar, Henlius' HLX02, for review

Fosun Pharma’s (HK: 02196) Henlius, a leading biotech company in China developing both biosimilar and innovative biologics, announced today that the European Medicines Agency (EMA) has officially accepted to review the Marketing Authorization Application (MAA) of its trastuzumab biosimilar HLX02, a copy version of Roche’s blockbuster Herceptin.

The European rights of this product have been out-licensed to its business partner Accord Healthcare. HLX02 is indicated for human epidermal growth factor receptor 2-positive (HER2+) early-stage breast cancer, HER2+ metastatic breast cancer, and untreated HER2+ metastatic gastric and gastroesophageal junction (GEJ) cancer.

The New Drug Application (NDA) of HLX02, a biosimilar of a classical targeted therapy for cancers, has been accepted for review by the National Medical Products Administration (NMPA) in China. The acceptance for review by the EMA demonstrates that the ‘China-developed’ biosimilar has entered the global stage with the hope to benefit patients globally.