Accord BioPharma Announces the Acceptance of BLA for HLX02 (a proposed trastuzumab biosimilar) by FDA

On April 5, 2023, Accord BioPharma announced that the FDA has accepted the Biologics License Application (BLA) for HLX02 referencing HERCEPTIN (trastuzumab) for adjuvant treatment of HER2-overexpressing breast cancer and treatments of HER-2 overexpressing metastatic breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma. The BLA submission included results from different studies comparing the structural and functional similarities between HLX02 and reference trastuzumab.

HLX02 was originally developed by Shanghai Henlius Biotech and was approved by the European Commission and China’s National Medical Products Administration (NMPA) in 2020. In 2021, Henlius granted Accord Biopharma the exclusive rights for the development and commercialization of HLX02 in the U.S. and Canada.