Posted by Michael Wonder on 24 Jun 2019
European Medicines Agency accepted first "China-Developed" biosimilar - Henlius HLX02 marketing authorisation application for review
21 June 2019 - First China-developed trastuzumab biosimilar accepted for MAA review by the EMA.
Henlius, a leading biotech company in China developing both biosimilar and innovative biologics, announced today that the EMA has officially accepted to review the marketing authorisation application of its trastuzumab biosimilar HLX02.
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 gastro-esophageal junction (GEJ) cancer.
The new drug application 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.
