Accord BioPharma’s Hercessi (Biosimilar, Herceptin) Receives the US FDA Approval

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Accord BioPharma’s Hercessi (Biosimilar, Herceptin) Receives the US FDA Approval


  • Accord BioPharma's Hercessi (trastuzumab-strf; 150mg; IV), a biosimilar to Herceptin (trastuzumab), has been approved by the US FDA to treat HER2 overexpressing breast and G/GEJ cancer in the US 
  • The approval was based on 2 studies incl. P-I (HLX02-HV01 & HLX02-HV02) trial assessing the single-dose, PK equivalence in healthy volunteers. P-III (HLX02-BC01) trial assessing the safety & efficacy in patients with HER2-overexpressing metastatic breast cancer in combination with docetaxel  
  • Company is also developing HERCESSI in 420mg, FDA decision is expected in Q4'24. In 2021, Shanghai Henlius (originator of Hercessi) granted exclusive development and commercial rights of HERCESSI to Accord in US and Canada 

Ref: PRNewswire | Image: Accord BioPharma

Related News:- Accord BioPharma Reports US FDA’s Acceptance of BLA for DMB-3115 (Biosimilar, Stelara)

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Disha Nankani

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.

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