Henlius Biotech tarafından geliştirilen biyobenzer trastuzumab , ilk biyobenzer olarak 17 Ağustos 2020 tarihinde Çin otoriteleri tarafından onaylanmış ve kullanıma sunulmuştur.
China’s First Trastuzumab Biosimilar Approved by NMPA
|SHANGHAI, Aug. 17, 2020 /PRNewswire/ — Shanghai Henlius Biotech Inc. (2696.HK) announced on August 14 that the trastuzumab biosimilar HLX02, developed and manufactured by Henlius independently, has been approved by the National Medical Products Administration (NMPA). On 27th July, HLX02 (EU brand name Zercepac®) has also been approved by the European Commission (EC), making HLX02 the first China-developed mAb biosimilar to be approved both in China and in the EU. The common name of HLX02 is trastuzumab injection (150mg/vial, without preservative) and it 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.|