Shots:
- The US FDA has granted approval to the company’s Hercessi (420mg), a biosimilar version of Herceptin (trastuzumab), for the treatment of HER2-overexpressing breast & G/GEJ adenocarcinoma. It is planned to be introduced in early 2025
- The approval was supported by the analytical, preclinical & clinical data showing similarity b/w Hercessi & Herceptin from the studies incl. P-I (HLX02-HV01 & 2) PK trials in healthy volunteers & a P-III (HLX02-BC01) trial with docetaxel in patients with HER2+ metastatic breast cancer
- Hercessi was developed by Shanghai Henlius Biotech. Accord BioPharma secured its exclusive development & commercialization rights across the US & Canada in 2021
Ref: Accord BioPharma | Image: Accord BioPharma | Press Release
Related News:- The NMPA Clears Shanghai Henlius’ IND Application of HLX17 (Biosimilar, Keytuda) for Treating Solid Tumors
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