On 23 April 2020, Shanghai Henlius Biotech, Inc announced that its Xuhui Facility is China's first EU certified good manufacturing practice (GMP) site to manufacture a self-developed antibody drug. In addition, Henlius’ HLX02 trastuzumab is the first China-developed copy biological to pass EU GMP inspection. It is hoped that this copy biological will be used for the treatment of human epidermal receptor-2-positive (HER2+) early-stage breast cancer, HER2+ metastatic breast cancer and HER2+ metastatic gastric cancer, if it receives approval recommendation from the European Medicines Agency (EMA), the regulatory submission of HLX02 was accepted to EMA in June 2019 [1].

The drug substance (DS) line and drug product (DP) line for HLX02 (trastuzumab for injection) passed the EU GMP on-site inspection and the company reported receiving two EU GMP Certificates. They stated that, as EU GMP approval represents ‘one of the most authoritative and rigorous inspections globally’, inspection results can be shared with countries that have signed Mutual Recognition Agreements with the European Union, such as Canada and the US. As such, this approval may be viewed as a passport for drugs to be launched in many international markets.

Despite pending EMA recommendation for approval of HLX02, Henlius has reached strategic cooperation agreements with Accord, Cipla, mAbxience and Jacobson Medical for the commercialization of HLX02 in over 80 countries and regions around the world.

Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that copy biologicals approved in China might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

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Reference
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 May 29]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-first-application-for-Chinese-made-biosimilar-HLX02

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