Bevacizumab non-originator biological approved in Russia

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Bevacizumab non-originator biological approved in Russia

Biosimilares/Novedades | Posted 22/01/2016 0 Post your comment

Russian biotechnology company Biocad announced on 30 November 2015 that the Russian Ministry of Health had approved the company’s bevacizumab non-originator biological drug, BCD-021. The drug is a non-originator biological of Roche’s cancer blockbuster Avastin (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 Russian Ministry of Health’s positive opinion on BCD-021 is based on the results of international clinical studies comparing the pharmacokinetics, efficacy, safety and immunogenicity of BCD-021 to Avastin. Biocad’s phase III study, which involved centres in Russia, Belarus and Ukraine was completed in December 2014. The design of the clinical trials was developed with the advice of the European Medicines Agency (EMA) for clinical trials of biosimilars of monoclonal antibodies.

Global sales of Avastin in 2014 amounted to US$7.4 billion. While in Russia, Avastin had sales of more than RUB 3.2 billion in 2014.

Bevacizumab is not the only non-originator biological Biocad has in the pipeline. The company received approval for its rituximab non-originator biological AcellBia (BCD-020) in April 2014 [1]. According to ClinTrials.gov the company is also carrying out a phase III clinical trial for another of its biological candidates, BCD-022, which is a non-originator biological of Roche’s blockbuster cancer drug Herceptin (trastuzumab) [2].

Editor’s comment
It should be noted that ‘non-originator biologicals’ approved in Russia might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (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.

Related article
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References
1. GaBI Online - Generics and Biosimilars Initiative. Rituximab non-originator biological approved in Russia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 22]. Available from: www.gabionline.net/Biosimilars/News/Rituximab-non-originator-biological-approved-in-Russia
2. GaBI Online - Generics and Biosimilars Initiative. Amgen and Pfizer seek deal with Russian non-originator biologicals firm [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 22]. Available from: www.gabionline.net/Pharma-News/Amgen-and-Pfizer-seek-deal-with-Russian-biosimilars-firm

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Source: Biocad