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Accord BioPharma Reports the US FDA Acceptance of BLA for HLX02, a Proposed Trastuzumab Biosimilar for Gastric Cancer and Other Indications

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Accord BioPharma

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

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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