The bevacizumab copy biological MIL60 (Betta Pharmaceuticals Ltd) and non-originator biological BCD-021 (Biocad) have demonstrated clinical equivalence for the treatment of non-squamous non-small cell lung cancer (NSCLC) in phase III trials.
Positive trial results for bevacizumab copies from Betta Pharmaceuticals and Biocad
Biosimilars/Research | Posted 15/10/2021 0 Post your comment
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 . It has been sold under the brand name Avastin by originator company Genentech/Roche.
At the European Society for Medical Oncology (ESMO) Congress 2021, investigators reported equivalence for the bevacizumab copy biological MIL60 in the treatment of NSCLC. MIL60 is developed by the Chinese firm Betta Pharmaceuticals Ltd.
The phase III randomized, double-blind study assigned patients with untreated advanced or recurrent NSCLC to receive MIL60 or originator bevacizumab, in combination with chemotherapy. The trial included 517 patients in total and was conducted in China.
The findings demonstrated equivalence with the originator compound in terms of efficacy, safety, pharmacokinetics, and immunogenicity. The investigators conclude that MIL60 is clinically equivalent to originator bevacizumab in the treatment of NSCLC.
Also at the ESMO Congress, the Russian biotechnology company BioCad presented findings on their bevacizumab non-originator biological, BCD-021. A randomized, double-blind, multicentre study compared the efficacy, safety, pharmacokinetics, and immunogenicity of BCD-021 to originator bevacizumab in patients with advanced NSCLC.
The trial included 357 patients from Russia, Belarus, Ukraine and India. Patients received BCD-021 or reference bevacizumab, plus chemotherapy. The study demonstrated equivalence between BCD-021 and originator bevacizumab in terms of objective response rate (ORR) risk difference and risk ratio, as well as safety, pharmacokinetics, and immunogenicity.
BCD-021 was approved as a non-originator biological in Russia in 2015 . Biocad is also developing a non-originator biological of the lymphoma and leukaemia drug rituximab, with plans to enter the EU market .
It should be noted that data of the studies presented in this article were published as an abstract and presented at a conference. These data and conclusions should be considered as preliminary until published in a peer-reviewed journal.
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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 15]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-bevacizumab
2. GaBI Online - Generics and Biosimilars Initiative. Non-originator biologicals approved in Russia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 15]. Available from: www.gabionline.net/biosimilars/general/Non-originator-biologicals-approved-in-Russia
3. GaBI Online - Generics and Biosimilars Initiative. Biocad announces positive rituximab results and plans to enter EU market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 15]. Available from: www.gabionline.net/biosimilars/research/Biocad-announces-positive-rituximab-results-and-plans-to-enter-EU-market
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Source: European Society for Medical Oncology (ESMO)