Accord BioPharma Reports the US FDA Acceptance of BLA for HLX02, a Proposed Trastuzumab Biosimilar for Gastric Cancer and Other Indications
Shots:
- The US FDA has accepted the BLA for HLX02, a proposed trastuzumab biosimilar for adjuvant treatment of HER2-overexpressing gastric cancer & other indication. HLX02 was originally developed by Accord's business partner Shanghai Henlius Biotech
- The submission was based on robust structural and functional analytical comparison data using multiple orthogonal techniques & head-to-head clinical studies b/w HLX02 & reference trastuzumab. These incl. comparative analytical studies, nonclinical studies, a P-I PK similarity study & a P-III study
- The results showed high similarity in quality, safety, & efficacy b/w HLX02 & reference trastuzumab. Additionally, the company intends to launch many additional biosimilars in the US market over the next 5yrs.
Ref: PRNewswire | Image: Henlius
Related News:- Henlius Reports the US FDA Acceptance of BLA for Proposed Biosimilar Trastuzumab HLX02
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