Accord BioPharma, the US speciality division of Intas, announced that the FDA has accepted its BLA for proposed trastuzumab biosimilar HLX02 for adjuvant treatment of HER2-overexpressing breast cancer, HER2-overexpressing metastatic breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. HLX02 was originally developed by Accord’s business partner Shanghai Henlius Biotech, Inc. In 2021, Henlius granted Accord the exclusive rights to develop and commercialise HLX02 in North America.
Separately, on 15 February 2023 Henlius announced the FDA acceptance of Henlius’ BLA for HLX02. It is unclear whether this is the same BLA as that which Accord has recently announced.