Posted by Michael Wonder on 18 Aug 2020
China's first trastuzumab biosimilar approved by NMPA
17 August 2020 - Shanghai Henlius Biotech announced on 14 August that the trastuzumab biosimilar HLX02, developed and manufactured by Henlius independently, has been approved by the National Medical Products Administration (NMPA).
On 27 July, HLX02 (Zercepac) was approved by the European Commission, making HLX02 the first China-developed monoclonal antibody biosimilar to be approved both in China and in the EU. HLX02 (trastuzumab injection 150 mg/vial, without preservative) is indicated for the treatment of HER2 positive early breast cancer, HER2 positive metastatic breast cancer and HER2 positive metastatic gastric cancer.
Trastuzumab has been included in China's National Reimbursement Drug List (NRDL) in 2017. According to the "Interim Measures for the Administration of Drugs in the NRDL", drugs in the NRDL are managed by their common names, and drugs with common names that have been listed in the NRDL will automatically enter the NRDL.
