Non-originator biologicals approved in Russia

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Non-originator biologicals approved in Russia

Biosimilars/General | Posted 10/01/2020 0 Post your comment

Last update: 10 January 2020

In Russia, the regulatory body for the approval of medicines is Russia’s Ministry of Health (Министерство здравоохранения Российской Федерации; Rosminzdrav, Minzdrav).

The Ministry of Health coordinates and oversees the operation of its subordinated services and agencies, including the Federal Supervision Service for Healthcare, the Federal Medical-Biological Agency, federal state institutions and unitary enterprises; and coordinates the work of the Federal Mandatory Health Insurance Fund.

Although Russia has a strong generics market, it has not yet developed a regulatory framework for biologicals or biosimilars. In fact, Russia has yet to define what a biosimilar is, and Russian Law does not yet recognize biosimilars as distinct products [1].

The first non-originator biological to receive approval in Russia was Biocad’s multiple sclerosis treatment Interferon beta-1b (BCD-033) in 2009. To date, Minzdrav has approved eight non-originator biologicals within the product classes of human growth hormone, granulocyte colony-stimulating factor (G-CSF), monoclonal antibodies and tumour necrosis factor (TNF)-inhibitor, for use in Russia, see Table 1.

Table 1: Minzdrav approved non-originator biologicals*
Company name, Country	Active substance	Therapeutic area	Authorization date	Manufacturer/ Company name
Acellbia (BCD-020)	rituximab	Chronic lymphocytic leukaemia Granulomatosis with polyangiitis Microscopic polyangiitis Non-Hodgkin’s lymphoma Rheumatoid arthritis	17 Apr 2014	Biocad
Avegra (BCD-021)	bevacizumab	Breast cancer Cervical cancer Colorectal cancer Glioblastoma Lung cancer Ovarian cancer Renal cell cancer	30 Nov 2015	Biocad
Elizaria	eculizumab	Paroxysmal nocturnal haemoglobinuria Atypical haemolytic uremic syndrome	9 Apr 2019	Generium
Flammegis	infliximab	Ankylosing spondylitis Crohn’s disease Psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis	Jul 2015	Celltrion
Herticad (BCD-022)	trastuzumab	Early breast cancer Metastatic breast cancer Metastatic gastric cancer	20 Jan 2016	Biocad
Infliximab (BCD-055)	infliximab	Ankylosing spondylitis Crohn’s disease Psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis	Feb 2018	Biocad
Rebif (BCD‑033)	interferon beta-1b	Multiple sclerosis	3 Mar 2009	Biocad
Remsima	infliximab	Crohn’s disease^# Ankylosing spondylitis Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis^#	13 Jul 2015	Celltrion
*Data collected on 12 December 2019. Source: Mindraz

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
Biosimilars approved in Europe

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Russia to harmonize biologicals regulations [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 10]. Available from: www.gabionline.net/Biosimilars/News/Russia-to-harmonize-biologicals-regulations

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Source: Mindraz