China’s Bio-Thera announced on 3 February 2020 that the phase III clinical trial comparing the safety and efficacy of BAT1706 versus the originator biological Avastin (bevacizumab) had met its primary endpoint. The company added that ‘the trial demonstrated equivalence in overall response rate (ORR) for the first-line treatment of patients with non-squamous non-small cell lung cancer’.

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.

Bio-Thera’s phase III clinical study (NCT03329911) is a multicentre, randomized, double-blind study evaluating the efficacy, safety, pharmacokinetics and immunogenicity of BAT1706 versus EU Avastin plus chemotherapy in patients with advanced non squamous non-small cell lung cancer.

The company announced in January 2020 that it had made a licensing agreement with India-based Cipla for BAT1706. Under the terms of the agreement, Cipla will have exclusive rights to distribute and market the drug in select emerging markets [1].

Bio-Thera intends to file for regulatory approval for BAT-1706 with the China National Medical Products Administration (NMPA), the European Medicines Agency and the US Food and Drug Administration in 2020.

If approved, BAT-1706 will be Bio-Thera’s second product to hit the market. Its adalimumab copy biological, Qletli (格乐立), received approval from China’s NMPA in 2019 [2] and is now available in China.

Bio-Thera is developing several proposed copy biologicals, including a version of Actemra/RoActemra (tocilizumab), which is currently being evaluated in a global phase III clinical trial. The company is also pursuing copy biologicals of Cosentyx (secukinumab), Simponi (golimumab) and Stelara (ustekinumab) [3].

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
Positive phase I results for Bio-Thera’s bevacizumab copy biological

References
1. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera advances bevacizumab and tocilizumab copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 28]. Available from: www.gabionline.net/Biosimilars/News/Bio-Thera-advances-bevacizumab-and-tocilizumab-copy-biologicals
2. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera gains Chinese approval for adalimumab copy biological and starts ustekinumab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 28]. Available from: www.gabionline.net/Biosimilars/News/Bio-Thera-gains-Chinese-approval-for-adalimumab-copy-biological-and-starts-ustekinumab-trial
3. GaBI Online - Generics and Biosimilars Initiative. Positive results for Bio-Thera’s arthritis copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 28]. Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-Bio-Thera-s-arthritis-copy-biologicals

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