Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

 Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

Henlius and Accord Receive CHMP’s Positive Opinion for its HLX02 (biosimilar, trastuzumab)

Shots:

  • The approval is based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy and safety of Zercepac (HLX02) vs Herceptin
  • Zercepac is developed under NMPA and EMA biosimilar guidelines and has been evaluated with the reference trastuzumab including comparative quality studies, preclinical studies, a P-I clinical study and a global multi-center P-III clinical study
  • Zercepac is a novel China-mAb approved in the EU for the treatment of HER2+ early breast cancer, HER2+ metastatic breast cancer, and HER2+ metastatic gastric cancer with an expected launch in China in 2020 while its manufacturing site has received EU GMP certificates

Click here to read full press release/ article | Ref: Henlius | Image: Behance

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

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