Gedeon Richter Submits Tocilizumab Biosimilar Application to EMA for Multiple Indications
• Gedeon Richter has submitted a marketing authorization application to the European Medicines Agency for its tocilizumab biosimilar (RGB-19), developed jointly with Mochida Pharmaceutical.
• The application includes comprehensive data from Phase I PK/PD studies in healthy volunteers and Phase III efficacy trials in rheumatoid arthritis patients, demonstrating similarity to RoActemra® across all parameters.
• If approved, the biosimilar will expand access to this IL-6 inhibitor for treating rheumatoid arthritis, juvenile idiopathic arthritis, giant cell arteritis, cytokine release syndrome, and COVID-19 across Europe.
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