Russian approval for non-originator interferon beta-1a Posted 10/03/2017

Russian biotechnology company Biocad announced on 3 March 2017 that the Russian Ministry of Health had approved the company’s interferon beta-1a non-originator biological drug, BCD-033. The drug is a non-originator biological of Merck’s multiple sclerosis blockbuster Rebif (interferon beta-1a).

Interferon beta-1a is a cytokine in the interferon family. It is produced by mammalian cells and used to treat multiple sclerosis (MS). Some claims have been made that interferons produce about 18–38% reduction in the rate of MS relapses.

The Russian Ministry of Health’s positive opinion on BCD-033 is based on the results of clinical studies comparing the pharmacokinetics, efficacy, safety and immunogenicity of BCD-033 to Rebif. Biocad’s phase III study, which was carried out in Russia was completed in July 2016. The design of the clinical trials was developed in accordance with European Medicine Agency (EMA) guidelines.

Interferon beta-1a is not the only non-originator biological Biocad has in the pipeline. The company received Russian approval for its rituximab non-originator biological AcellBia (BCD-020) in April 2014 [1] and for its bevacizumab non-originator biological (BCD-021) in November 2015 [2]. According to ClinTrials.gov, the company is also carrying out a phase III clinical trial for BCD-022, which is a non-originator biological of Roche’s blockbuster cancer drug Herceptin (trastuzumab) [3]. In addition, the company is also carrying out phase I and II trials for BCD-054, a peginterferon beta-1a non-originator biological.

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.

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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 2017 Mar 10]. Available from: www.gabionline.net/Biosimilars/News/Rituximab-non-originator-biological-approved-in-Russia
2. GaBI Online - Generics and Biosimilars Initiative. Bevacizumab non-originator biological approved in Russia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 10]. Available from: www.gabionline.net/Biosimilars/News/Bevacizumab-non-originator-biological-approved-in-Russia
3. 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 2017 Mar 10]. Available from: www.gabionline.net/Pharma-News/Amgen-and-Pfizer-seek-deal-with-Russian-non-originator-biologicals-firm

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Source: Biocad, ClinicalTrials.gov

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