According to Credit Suisse an estimated US$113 billion of the US$299 billion in annual global sales of biologicals (based on 2022 sales) would no longer have patent protection by 2023 [1]. This will open the door for new biosimilar entrants. While blockbusters, including Lantus (insulin glargine) and Neulasta (pegfilgrastim), lost their patents protection in Europe and the US between 2014 and 2017 [2], even more patents are scheduled to expire in the near future [2].

Patent expiries coming soon will include the US patent for the world’s best-selling drug, Humira (adalimumab). In Europe, Humira’s composition of matter patent expired in October 2018 [2], opening the door to 10 adalimumab biosimilars already approved by the European Commission [3]. In the US, however, AbbVie gained an extension to its US patent and has made numerous deals with biosimilar makers delaying their products until 2023 [4].

The expiry of all these patents creates an opportunity for biosimilar manufacturers around the world and Chinese producers are also expected to take advantage of this situation. China-based Shanghai Henlius Biopharmaceutical (Henlius) had its trastuzumab biosimilar Zercepac (HLX02) approved in Europe in July 2020 as the first China-made biosimilar to receive approval in Europe [5] and others are expected to follow soon.

Henlius has three copy biologicals approved in China: adalimumab (Handa Yuan; 汉达远; HLX03), rituximab (Hanlikon; 汉利康; HLX01) and trastuzumab (Han Quyou; 汉曲优; HLX02) [5]. The company is also conducting phase III studies on other candidates, including bevacizumab (HLX04) and serplulimab (HLX10), and is also working on copy biologicals of daratumumab (HLX15) [6] and pertuzumab (HLX22) [7].

In addition, a growing number of Chinese players, including Innovent Biologics, Qilu, Bio-Thera Solutions and Zhejiang Hisun Pharmaceuticals also already have copy biologicals approved in China [5], and others, such as SinoCelltech, are advancing clinical studies for copy biologicals, including adalimumab and bevacizumab.

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 articles
Investment increasing pipeline of copy biologicals in China

Improved regulation favouring copy biologicals in China

Cancer driving the need for copy biologicals in China

The state of play for copy biologicals in China

References
1. Credit Suisse. Global Pharmaceutical Industry: Catching up with Biosimilars. 29 November 2018.
2. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
3. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for bevacizumab biosimilar from Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-bevacizumab-biosimilar-from-Samsung-Bioepis 
4. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim finally signs licensing deal for Humira biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Pharma-News/Boehringer-Ingelheim-finally-signs-licensing-deal-for-Humira-biosimilar 
5. GaBI Online - Generics and Biosimilars Initiative. Copy biologicals approved in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Biosimilars/General/Copy-biologicals-approved-in-China 
6. GaBI Online - Generics and Biosimilars Initiative. China accepts IND application for daratumumab copy biological HLX15 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Biosimilars/News/China-accepts-IND-application-for-daratumumab-copy-biological-HLX15 
7. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pertuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pertuzumab

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