The basis of the pathogenetic therapy of multiple sclerosis (MS) are drugs that change the course of MS (MSITS). The dominant role among all MDDMS is currently occupied by four first-line drugs – three beta-interferon and glatiramer acetate. The therapeutic efficacy of PITRS has been confirmed by studies that meet the modern requirements of evidence-based medicine. The results of double-blind, placebo-controlled clinical trials have shown that long-term therapy with MITRS can significantly reduce the clinical and MRI activity of the disease and limit the progression of disability in patients with MS.

In 2010–2015 The arsenal of drugs for the treatment of MS was supplemented with drugs for oral administration with fundamentally new mechanisms of action: fingolimod, teriflunomide, dimethyl fumarate. The first of these drugs, fingolimod (Gilenia, Novartis), was registered in Russia in 2010 for the treatment of relapsing-remitting MS.

In 2014, the first reproduced domestic fingolimod was registered in Russia – Nesclair (BioIntegrator LLC, Russia), which is chemically identical to the original drug. Fingolimod has a relatively simple structure, so modern methods of analysis allow you to check the identity of the molecules of the original and reproduced drugs. Registration of reproduced fingolimods requires confirmation of bioequivalence in comparative preclinical and clinical studies, the identity of the active substance by comparative physicochemical studies and compliance with the requirements of good manufacturing practice (GMP). At the same time, the question of the therapeutic equivalence of such drugs remains open, which leads to therapeutic risks and problems of ineffective spending of budget funds.

The main source of evidence on the safety and tolerability of generic drugs after their registration is the organization and maintenance of the pharmacovigilance system, the construction of the pharmacovigilance system.

Good pharmacovigilance practice in our country has made it possible to determine the effectiveness and, which is important for chronic patients, the safety of the reproduced fingolimod. The organization and maintenance of the pharmacovigilance system made it possible to quickly collect information on the types and frequency of adverse drug events.

The observational program on the use of the domestic generic drug fingolimod (Nesclair, BioIntegrator LLC, Russia) in patients with relapsing multiple sclerosis, conducted in 8 clinical centers in 7 different regions of Russia, demonstrated a good safety profile, comparable to published data on the use of the original drug Gilenia … Building a pharmacovigilance system and adhering to good pharmacovigilance practices made it possible to strengthen the position of the generic drug and increase the availability of the drug to various segments of the population with this pathology at the expense of budget funds.

M. Koval1, N. V. Khachanova2, M. V. Zhuravleva3, A. G. Fisun1, V. Davydovskaya1, K. A. Kokushkin1

1 State budgetary institution of the city of Moscow “Clinical Research Center and assessment of medical technologies of the Moscow Department of Health”, Russian Federation, 121096, Moscow, st. Minskaya, 12, bldg. 2

2 Federal State Budgetary Educational Institution of Higher Education Russian National Research Medical University named after N.I. Pirogov ” Ministry of Health of the Russian Federation, Russian Federation, 117997, Moscow, st. Ostrovityanova, 1

3 Federal State Autonomous Educational Institution of Higher Education “The First Moscow State Medical University named after I.M. Sechenov ” Ministry of Health of the Russian Federation Russian Federation, 119991, Moscow, st. Trubetskaya, 8, bldg. 2

* Safety and Risk of Pharmacotherapy 2018.6 (1) .pdf