Trastuzumab non-originator biological approved in Russia

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Trastuzumab non-originator biological approved in Russia

Biosimilars/News | Posted 26/02/2016 0 Post your comment

Russian biotechnology company Biocad announced on 20 January 2016 that the Russian Ministry of Health had approved the company’s trastuzumab non-originator biological, BCD-022. The drug is a non-originator biological of Roche’s breast cancer blockbuster Herceptin (trastuzumab).

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

The Russian Ministry of Health’s positive opinion on BCD-022 is based on the results of a randomized multicentre clinical study comparing the pharmacokinetics, immunogenicity, safety and efficacy of BCD-022 to the originator Herceptin. Biocad’s phase III study, which involved centres in Russia, Belarus, India and Ukraine, was planned to be completed in March 2015.

Herceptin had 2014 worldwide sales of CHF 6.3 billion (US$6.2 billion). US patents on the drug expire in June 2019 and European patents already expired in July 2014 [1].

Biocad also received Russian approval for its bevacizumab non-originator biological drug, BCD-021, in November 2015 [2] and for its rituximab non-originator biological AcellBia (BCD-020) in April 2014 [3]. All three of Biocad’s non-originator biologicals were developed in the context of a federal innovative project that was approved by the Presidential Commission on Modernization and Technological Advancement.

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.

References
1.    GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 26]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
2.    GaBI Online - Generics and Biosimilars Initiative. Bevacizumab non-originator biological approved in Russia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 26]. Available from: www.gabionline.net/Biosimilars/News/Bevacizumab-non-originator-biological-approved-in-Russia
3.         GaBI Online - Generics and Biosimilars Initiative. Rituximab non-originator biological approved in Russia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 26]. Available from: www.gabionline.net/Biosimilars/News/Rituximab-non-originator-biological-approved-in-Russia

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Source: Biocad, ClinicalTrials.gov