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
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