China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has approved three bevacizumab.
Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.
The NMPA announced on 26 November 2021 that it had approved MIL60, a bevacizumab copy biological. MIL60 was developed by China-based Betta Pharmaceuticals (Betta) in collaboration with partner Beijing Mabworks Biotech (Mabworks). The copy biological has been approved for the treatment of advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) and metastatic colorectal cancer.
The approval was based on data from a multicentre, double-blind, randomized, parallel-group phase III study in adult patients with NSCLC. The study, which was carried out in China, included 517 patients and was completed in June 2020. Positive results from the study were presented at the European Society for Medical Oncology (ESMO) Congress 2021. Findings from the study, according to Betta, demonstrated equivalence with originator bevacizumab in terms of efficacy, safety, pharmacokinetics and immunogenicity [1].
MIL60 is the first copy biological to be approved in China for Betta and Mabworks [2].
This approval was followed by the announcement on 1 December 2021 by TOT BIOPHARM that its self-developed bevacizumab copy biological, Pusintin (朴欣汀, TAB008) was approved by the NMPA for the treatment of patients with advanced, metastatic or recurrent non-squamous NSCLC and patients with metastatic colorectal cancer.
The approval was based on data from a multicentre, double-blind, randomized, parallel-group phase III study. The study, which enrolled 549 patients (277: TAB008 and 272: reference bevacizumab). According to TOT BIOPHARM, ‘the results of this clinical trial prove that TAB008 and reference bevacizumab used for the first-line treatment of advanced or recurrent non-squamous NSCLC have similar efficacy, safety, immunogenicity profiles and pharmacokinetic characteristics’.
Then on 3 December 2021, China-based drugmaker Shanghai Henlius Biotech (Henlius) announced that its bevacizumab copy biological, Hanbeitai (汉贝泰, HLX04) had been approved by the NMPA. The product has been approved for the treatment of metastatic colorectal cancer and unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer.
The approval was supported by a series of study data, including comparative pharmaceutical quality studies, comparative non-clinical studies, comparative clinical studies. In contrast to other approved bevacizumab copy biologicals in China, the phase III study for Hanbeitai was conducted in Chinese patients with metastatic colorectal cancer, which helps to accumulate more clinical evidence and experience of bevacizumab in this patient population [3]. The results of the study, according to Henlius, showed that Hanbeitai ‘is highly similar to the originator’.
Hanbeitai is the company's fourth monoclonal antibody approved in China. Henlius has also gained NMPA approval for its rituximab copy biological, Hanlikon (汉利康, HLX01), trastuzumab copy biological Han Quyou (汉曲优, HLX02: Zercepac in Europe) and adalimumab copy biological, Handa Yuan (汉达远, HLX03) [2].
Finally, another Chinese company, Bio-Thera Pharmaceuticals (Bio-Thera) was hoping to become the first Chinese company to gain US Food and Drug Administration (FDA) approval, for its candidate bevacizumab biosimilar, BAT1706. The FDA accepted the Biologics License Application (BLA) for BAT1706 in January 2021 and had set a goal date for a decision of 27 November 2021 [4]. However, this date has passed with no announcement from either Bio-Thera or FDA.
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
1. GaBI Online - Generics and Biosimilars Initiative. Positive trial results for bevacizumab copies from Betta Pharmaceuticals and Biocad [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Dec 10]. Available from: www.gabionline.net/biosimilars/research/positive-trial-results-for-bevacizumab-copies-from-betta-pharmaceuticals-and-biocad
2. GaBI Online - Generics and Biosimilars Initiative. Copy biologicals approved in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Dec 10]. Available from: www.gabionline.net/biosimilars/general/copy-biologicals-approved-in-china
3. GaBI Online - Generics and Biosimilars Initiative. Progress for bevacizumab copy biologicals from Henlius and Innovent [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Dec 10]. Available from: www.gabionline.net/biosimilars/research/progress-for-bevacizumab-copy-biologicals-from-henlius-and-innovent
4. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for bevacizumab biosimilar BAT1706 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Dec 10]. Available from: www.gabionline.net/biosimilars/news/FDA-accepts-application-for-bevacizumab-biosimilar-BAT1706
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Source: Betta Pharmaceuticals, Clinicaltrials.gov, Henlius, NMPA, TOT BIOPHARM
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