Russian biotechnology company Generium has announced the registration of Efictel, the first Russian biosimilar of natalizumab. This milestone, achieved on February 12, 2026, marks the end of the long-standing monopoly held by the American drug Tysabri (Biogen) and is expected to significantly reduce government expenditures on high-cost therapy.
The registration of Efictel (Registration Number: LP-№(013345)-(RG-RU)) represents a critical step toward national drug security. Until now, patients with severe forms of multiple sclerosis (MS) in Russia relied exclusively on imported original medication. Generium now provides a domestic alternative with a full-cycle production process located at its facility in the Vladimir Region.
“Natalizumab has secured a vital place in global clinical practice for treating multiple sclerosis and is indicated for patients with severe disease progression. The first Russian biosimilar, Efictel, is a new therapeutic option that expands patient access to highly effective treatment in Russia.”
— Daniil Talyansky, CEO of JSC Generium
Therapeutic Profile and Indications
Efictel is approved as a concentrate for solution for infusion (15 ml vials) for the treatment of adult patients (18+) with highly active relapsing-remitting multiple sclerosis. As a monoclonal antibody, the drug works by blocking receptors on immune cells, preventing them from crossing the blood-brain barrier and damaging the protective myelin sheath of nerves.
According to the State Register of Medicinal Products (GRLS), the drug is included in the Vital and Essential Drugs List (VED/ZHNVLP) and is available strictly by prescription. The current registration certificate is valid until January 26, 2031.
Economic Impact and Market Dynamics
The entry of a Russian player fundamentally alters the landscape of the state-funded “14 High-Cost Nosologies” (14 VZN) program. The presence of a second drug on the market shifts procurement into a competitive environment. Experts anticipate several key outcomes:
- Price Reduction: The introduction of biosimilars typically brings a discount of 20–40% compared to the original drug’s price.
- Local Manufacturer Preferences: As a full-cycle local producer, Generium will benefit from the “Three’s a Crowd” rule in government tenders, providing a competitive edge over foreign suppliers.
- Expanded Patient Coverage: The budget savings realized through competitive bidding will allow the healthcare system to provide modern therapy to a larger number of patients within existing budget limits.
Development Milestones
The development of Efictel spanned several years. Following the authorization of Phase I clinical trials in February 2023, a large-scale Phase III study was launched in December of the same year. This pivotal study successfully proved the efficacy and safety of the Russian biosimilar in comparison to the American original.
Looking ahead, Generium is continuing its research and development efforts for other complex MS therapies, including a biosimilar of ocrelizumab (originally marketed as Ocrevus by Roche).
Source: Based on materials from the GRLS Ministry of Health of the Russian Federation, Generium Press Service, and RAAS.
