The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 29 May 2020 that it had recommended granting of marketing authorization for a biosimilar trastuzumab product.
The trastuzumab biosimilar, which will be called Zercepac (HLX02), has been developed by China-based drugmaker Shanghai Henlius Biotech (Henlius). Henlius out-licensed the European rights for HLX02 to India-based generics maker Accord Healthcare (a subsidiary of Intas Pharmaceuticals) in June 2018. The pair submitted their application to the EMA back in June 2019 [1].
The drug is a biosimilar of Roche’s Herceptin (trastuzumab). Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.
Henlius gained European Union (EU) good manufacturing practice (GMP) certification of its Xuhui facility in China in April 2020 [2]. The company said at the time that it was likely that the copy biologicals produced at the site would soon be available internationally.
The CHMP positive opinion will now be considered by the European Commission (EC). Once approved, the EC will grant a centralized marketing authorization for member countries of the European Union (EU). The decision on the EC’s approval is expected in the next two to three months.
Assuming it receives final EU approval, Zercepac will be the first China-made biosimilar to receive approval in Europe. Accord Healthcare has already received approval for two biosimilars in Europe. The company’s filgrastim biosimilar Accofil was approved in September 2014 and its pegfilgrastim biosimilar Pelgraz was approved in September 2018 [3].
Zercepac will be the sixth trastuzumab biosimilar to receive approval in Europe. Ontruzant, produced by Samsung Bioepis, was the first to be approved in November 2017. This was followed by Celltrion Healthcare’s Herzuma in February 2018, Amgen/Allergan’s Kanjinti in May 2018, Pfizer’s Trazimera in July 2018 and Biocon/Mylan’s Ogivri in December 2018 [3].
Henlius has also received approval from China’s medicines regulatory agency, National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA, 国家食品药品监督管理局), for its trastuzumab biosimilar HLX02 in China [4].
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China publishes draft guideline for trastuzumab copy biologicals
References
1. 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 Jun 5]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-first-application-for-Chinese-made-biosimilar-HLX02
2. 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 Jun 5]. Available from: www.gabionline.net/Biosimilars/General/EU-approves-Henlius-copy-biologicals-facility-in-China
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 5]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 5]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-trastuzumab
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