Posted by Michael Wonder on 08 Apr 2023
Accord BioPharma announces US FDA acceptance of biologics license application for proposed biosimilar trastuzumab HLX02
5 April 2023 - The biosimilar for Herceptin seeks to treat several forms of HER2 cancer.
Accord BioPharma announced today the US FDA has accepted the biologics license application for HLX02 (a proposed trastuzumab biosimilar) for adjuvant treatment of HER2 over-expressing breast cancer, the treatment of HER2 over-expressing metastatic breast cancer, and the treatment of HER2 over-expressing metastatic gastric or gastro-esophageal junction adenocarcinoma.
