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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