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EC approval for trastuzumab biosimilar Zercepac Posted 04/09/2020

The European Commission (EC) has granted marketing authorization for the trastuzumab biosimilar Zercepac (HLX02) on 27 July 2020. The product is produced by the Shanghai Henlius Biopharmaceutical Co Ltd (Henlius), making it the first China-made biosimilar to receive approval in Europe.

Trastuzumab is a monoclonal antibody treatment for human epidermal growth factor receptor 2 positive (HER2+) breast and gastric cancer. The antibody targets the HER2 receptor to stop the reproduction of cancer cells. The originator product, Herceptin, is sold by Roche/Genentech.

The approval by the EC on 27 July 2020 follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 29 May 2020 [1].

Henlius out-licensed the European rights for Zercepac (HLX02) to India-based generics maker Accord Healthcare (a subsidiary of Intas Pharmaceuticals) in June 2018. The pair submitted their application to EMA back in June 2019 [2].

The EC has approved Zercepac for the treatment of HER2+ early breast cancer, HER2+ metastatic breast cancer, and HER2+ metastatic gastric cancer. This is based on a series of quality, preclinical and clinical studies confirming that Zercepac has biosimilarity and comparable efficacy and safety to the reference product.

The news makes Zercepac the first China-made biosimilar to receive approval in Europe, and overall the sixth trastuzumab biosimilar to receive approval in Europe.

Commenting on the news, CEO of Henlius Dr Scott Liu said: ‘The approval of Zercepac in the EU is a significant milestone of our global strategy. This achievement announces that our capability in the development and manufacturing of biologics has reached international standards. In the future, Henlius will provide more high-quality biologics as new treatment options to benefit patients worldwide’.

The EU approved Henlius’ manufacturing facility in China in April 2020 [3], which will facilitate the international sale of biosimilars produced by the company. Also, the China’s National Medical Products Administration (NMPA) had accepted an investigational new drug application (IND) for HLX4, a denosumab copy biological by Henlius [4].

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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of trastuzumab biosimilar Zercepac [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 4]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-trastuzumab-biosimilar-Zercepac 
2. GaBI Online - Generics and Biosimilars Initiative. EMA accepts first application for Chinese-made biosimilar HLX02 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 4]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-first-application-for-Chinese-made-biosimilar-HLX02 
3. GaBI Online - Generics and Biosimilars Initiative. EU approves Henlius copy biologicals facility in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 4]. Available from: www.gabionline.net/Biosimilars/General/EU-approves-Henlius-copy-biologicals-facility-in-China 
4. GaBI Online - Generics and Biosimilars Initiative. China accepts IND application for denosumab copy biological HLX14 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 4]. Available from: www.gabionline.net/Biosimilars/News/China-accepts-IND-application-for-denosumab-copy-biological-HLX14 

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