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Henlius Reports the US FDA Acceptance of BLA for Proposed Biosimilar Trastuzumab HLX02

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Henlius

Henlius Reports the US FDA Acceptance of BLA for Proposed Biosimilar Trastuzumab HLX02

Shots:

  • The US FDA has accepted the BLA for the proposed biosimilar trastuzumab HLX02 (submitted by the company's partner Accord BioPharma) indicated for breast cancer & metastatic gastric cancer corresponding to all the approved indications of trastuzumab
  • The submission was based on robust structural & functional analytical data using multiple orthogonal techniques & head-to-head studies incl. comparative analytical studies, nonclinical studies, a P-I PK similarity study & P-III study of HLX02 vs trastuzumab which showed that HLX02 & reference trastuzumab are highly similar in terms of quality, safety & efficacy
  • HLX02 was approved in 30+ countries & Henlius focuses to advance the delivery of high-quality, affordable & innovative therapies to patients globally

Ref: PRNewswire | Image: Henlius

Related News:- Henlius Signs an Exclusive License Agreement with Accord for HLX02 (biosimilar- trastuzumab) in the US and Canada

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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