Accord BioPharma’s Hercessi 420mg (Biosimilar, Herceptin) Receives the US FDA’s Approval to Treat Various HER2-Overexpressing Cancer
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- 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: PRNewswire | Image: Accord BioPharma
Related News:- Accord BioPharma’s Hercessi (Biosimilar, Herceptin) Receives the US FDA Approval
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
