Chinese biosimilars have gained global traction, with companies like Henlius and Bio-Thera securing international approvals. Despite challenges, China’s innovation and partnerships position it as a key biopharmaceutical player.
In recent years, Chinese biopharmaceutical companies have made remarkable progress in the development and internationalization of biosimilars. By early 2024, China had solidified its position as a global hub for biotech innovation, attracting significant attention and investment from multinational pharmaceutical companies [1] and reshaping the global biosimilars landscape. With substantial contributions to healthcare accessibility and affordability, Chinese biosimilars are carving out a niche in competitive international markets, including Asia, Europe, and North America.
China’s biosimilar industry has evolved rapidly since 2017, with key players such as Shanghai Henlius Biotech (Henlius), Bio-Thera Solutions (Bio-Thera), and Innovent Biologics (Innovent) leading the charge. These companies have successfully developed monoclonal antibody biosimilars – including bevacizumab, tocilizumab, and trastuzumab – into various international markets. Table 1 lists 22 biologicals (spanning 17 active ingredients) developed by Chinese pharmaceutical companies, detailing their development stages and global approval status.
Notably, Henlius’ trastuzumab has gained approval (marketed by Accord) in Canada, Europe and the US [2-4], while Bio-Thera secured approvals for bevacizumab (marketed by Sandoz) and tocilizumab (marketed by Biogen) in Europe and the US [3, 4]. Innovent’s bevacizumab biosimilar was approved in Indonesia in 2022 [5]. These milestones underscore China's ability to meet stringent international regulatory requirements and address diverse therapeutic needs worldwide.
Table 1: Development status of Chinese biosimilars in foreign markets (2017–2023)
| Table 1: Development status of Chinese biosimilars in foreign markets (2017–2023)
|
| Active ingredient
|
Country
|
Status
|
Date created
|
Biosimilar applicant
|
| Bevacizumab
|
USA
|
Early phase
|
18 Mar 2019
|
Teruisi
|
| Europe, USA
|
Pivotal clinical
|
20 Oct 2017
|
Bio-Thera; Cipla; Biomm
|
| Brazil
|
BLA
|
11 Apr 2023
|
Boan Biotech
|
| Indonesia
|
BLA approved
|
13 Jun 2022
|
Innovent; PT Etana Biotech-nologies Indo-nesia; Coherus
|
| Denosumab
|
Australia, Europe, Japan, USA
|
Pivotal clinical
|
3 Sep 2022
|
Henlius; Organon
|
| Europe, Japan, USA
|
Early phase
|
23 Oct 2020
|
Boan Biotech
|
| Eculizumab
|
Europe
|
BLA approved
|
26 May 2023
|
AffaMed Thera-peutics; Samsung Bioepis
|
| Golimumab
|
Europe, USA
|
Pivotal clinical
|
11 Dec 2020
|
Bio-Thera; Pharmapark
|
| Insulin Aspart
|
Bangladesh, Kazakhstan BLA
|
Approved
|
26 May 2022
|
Gan & Lee
|
| Insulin Glargine
|
USA
|
Early phase
|
24 Jan 2022
|
Yichang HEC Changjiang; Lannett
|
| Ipilimumab
|
Australia
|
Early phase
|
22 Apr 2018
|
CStone Pharmaceuticals
|
| Omazumab
|
Europe
|
Pivotal clinical
|
3 Mar 2021
|
CSPC Pharmaceutical
|
| Pegfilgrastim
|
Europe, USA
|
Early phase
|
9 Nov 2020
|
Qilu
|
| Pertuzumab
|
Europe
|
Pivotal clinical
|
24 Feb 2022
|
Henlius; Organon
|
| Ranibizumab
|
Europe
|
Pivotal clinical
|
25 Feb 2019
|
Qilu
|
| Europe, Canada, USA
|
BLA approved
|
18 Aug 2021
|
AffaMed Thera-peutics; Samsung Bioepis
|
| Rituximab
|
USA
|
Pivotal
|
30 Mar 2020
|
Henlius; Laboratorio SIDUS; Farma de Colombia; Eurofarma
|
| Secukinumab
|
Japan, Poland
|
Pivotal clinical
|
12 May 2022
|
Bio-Thera
|
| Teriparatide
|
USA
|
BLA approved
|
4 Oct 2019
|
Pelican Expression Technology; Alvogen; NT Pharma; Theramex
|
| Tocilizumab
|
Europe, USA
|
BLA approved
|
29 Sep 2023
|
Bio-Thera; Biogen
|
| Trastuzumab
|
Australia, Europe
|
BLA approved
|
29 Jul 2020
|
Henlius; mAbxience; Eurofarma; Cipla; Accord; Biopharma
|
| Ustekinumab
|
Europe, USA
|
Pivotal clinical
|
24 Jan 2021
|
Bio-Thera; Hikma; Pharmapark
|
A key driver of Chinese biosimilars’ internationally is their partnerships with global pharmaceutical companies and overseas expansion. Companies such as Bio-Thera, Boan, Genor, Henlius, Innovent, and Qilu have established a presence abroad.
Despite these advancements, challenges persist. The crowded biosimilar market in China has sparked intense domestic competition, occasionally leading to resource wastage and clinical trials delays. Additionally, regulatory barriers in international markets demand meticulous adaptation to local standards, often necessitating reformulations and additional trials. Overcoming these obstacles will require sustained innovation, strategic partnerships, and investment in global regulatory science.
Looking ahead, Chinese biosimilars hold the potential to transform global health care by improving access to affordable, effective treatments. By prioritizing quality, safety, and compliance with international regulations, China is poised to play a pivotal role in the future of the biopharmaceutical industry.
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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References
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