The state-of-the-art 50,000 m² facilities have been operational under good manufacturing practice (GMP) conditions since 2018. They include drug substance capacities equipped with two 2,000 L single-use bioreactors that can be expanded and drug product capacities for filling vials and pre-filled syringes.

The Pfizer Biologics (Hangzhou) site was planned to manufacture adalimumab, bevacizumab and trastuzumab copy biologicals for the China market. However, after commercially and technically evaluating other products for the site, Pfizer decided that ‘none reached the level of activity for the scale of the site’. The company added that after carrying out a ‘comprehensive review of the biosimilars market and the company’s global manufacturing network’ it would halt its biosimilar programmes in the country.

WuXi Biologics expects to start production at the plant to commence shortly after closure of the deal, which is expected in the first half of 2021. However, neither Pfizer nor Wuxi Biologics disclosed the products that would be made there.

WuXi Biologics was the first biologicals maker to receive GMP certification from the European Medicines Agency (EMA) [1]. The company also has facilities in China, Ireland, Singapore and the US [2], as well as in Germany, giving it a total estimated capacity for biopharmaceutical production exceeding 300,000 litres after 2023.

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.

Related article
Copy biologicals approved in China

References
1. GaBI Online - Generics and Biosimilars Initiative. First Chinese biologicals maker receives EMA GMP certification [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Pharma-News/First-Chinese-biologicals-maker-receives-EMA-GMP-certification
2. GaBI Online - Generics and Biosimilars Initiative. WuXi Biologics expands its biologicals manufacturing facilities [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Biosimilars/General/WuXi-Biologics-expands-its-biologicals-manufacturing-facilities

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