Gedeon Richter announced on March 27, 2025, that the European Medicines Agency (EMA) has accepted its marketing authorization application (MAA) for RGB-19, a proposed biosimilar to Roche's RoActemra® (tocilizumab). The submission represents a significant step in expanding access to this important biological therapy across multiple inflammatory and autoimmune conditions.
RGB-19, developed in partnership with Japan's Mochida Pharmaceutical Co., Ltd., targets the same indications as the reference product, including rheumatoid arthritis, juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, cytokine release syndrome, and COVID-19.
Comprehensive Clinical Data Package
The MAA submission includes extensive analytical and clinical evidence demonstrating biosimilarity to the reference product. Richter's data package comprises results from a Phase I pharmacokinetic/pharmacodynamic (PK/PD) similarity study conducted in healthy male volunteers and a multicenter Phase III clinical trial evaluating efficacy and safety in patients with rheumatoid arthritis.
According to the company, RGB-19 has demonstrated equivalence to RoActemra® in terms of pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity profiles across the studied populations. These findings support the biosimilar's potential use across all indications currently approved for the originator product.
Tocilizumab works by inhibiting interleukin-6 (IL-6) signaling, a key inflammatory pathway implicated in several autoimmune and inflammatory conditions. It was the first biologic agent to target this specific mechanism.
Market Competition and Strategic Importance
Dr. Erik Bogsch, Head of Richter's Biotechnology Business Unit, emphasized the strategic importance of this submission: "The submission of the tocilizumab biosimilar to the EMA is yet another milestone in building Richter's affordable medicines portfolio. This biosimilar – when approved – will provide access to a broad range of our patients in Europe to this important biological drug."
However, Richter may face significant competition in the European tocilizumab market. Several biosimilar versions have already received regulatory approval, potentially creating a competitive landscape by the time RGB-19 reaches the market.
Company Background and Strategy
Gedeon Richter, headquartered in Hungary, has been expanding its biosimilar portfolio as part of its broader strategy to provide affordable treatment options. With a market capitalization of EUR 4.7 billion and annual sales of EUR 2.2 billion in 2024, the company operates Central Europe's largest R&D hub.
The company has established itself as a significant player in neuropsychiatry and women's healthcare, while continuing to strengthen its biotechnology and general medicines portfolios. Richter's focus on sustainable growth includes substantial investments in research and development, manufacturing excellence, and digital transformation to advance medical innovation.
The EMA's review process for biosimilar applications typically takes approximately one year, suggesting that a decision on RGB-19 could be expected in early 2026, pending any requests for additional information during the review period.
