Richter Gedeon Submits Biosimilar Tocilizumab Application to EMA
Richter Gedeon Nyrt. seeks regulatory approval for RGB-19, a biosimilar treatment for various conditions including COVID-19.
Richter Gedeon Nyrt.
has submitted an application to the European Medicines Agency (EMA) for the registration of its biosimilar tocilizumab product, identified as RGB-19, for several indications.
This submission marks a significant milestone for Richter in its efforts to enhance its portfolio of affordable medications.
RGB-19 is a collaborative development between Richter and Japan's Mochida Pharmaceutical Co., Ltd.
The EMA has acknowledged the marketing authorization application for the biosimilar tocilizumab candidate, according to a statement from the pharmaceutical company.
Tocilizumab is recognized as the first IL-6 receptor antagonist biological agent and is used in the treatment of multiple conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, giant cell arteritis, cytokine release syndrome, and COVID-19.
Richter has presented a comprehensive analytical and clinical data package, which includes results from a Phase I pharmacokinetic and pharmacodynamic (PK/PD) study, as well as data from a multicenter clinical trial involving patients with rheumatoid arthritis.
The data package indicates that the tocilizumab developed by Richter demonstrates results comparable to the reference product in terms of efficacy, drug safety, and immunogenicity for the studied population.
This complete data package forms the basis for the approval of biosimilar products across all therapeutic indications of the originator.
RGB-19 is part of Richter's ongoing collaboration with Mochida Pharmaceutical Co., Ltd. The submission of the biosimilar tocilizumab application to the EMA reflects Richter's commitment to establishing a diverse portfolio of affordable drug options.
The approval of biosimilars aims to ensure access to this critical biological therapy for a wide patient population in Europe.
has submitted an application to the European Medicines Agency (EMA) for the registration of its biosimilar tocilizumab product, identified as RGB-19, for several indications.
This submission marks a significant milestone for Richter in its efforts to enhance its portfolio of affordable medications.
RGB-19 is a collaborative development between Richter and Japan's Mochida Pharmaceutical Co., Ltd.
The EMA has acknowledged the marketing authorization application for the biosimilar tocilizumab candidate, according to a statement from the pharmaceutical company.
Tocilizumab is recognized as the first IL-6 receptor antagonist biological agent and is used in the treatment of multiple conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, giant cell arteritis, cytokine release syndrome, and COVID-19.
Richter has presented a comprehensive analytical and clinical data package, which includes results from a Phase I pharmacokinetic and pharmacodynamic (PK/PD) study, as well as data from a multicenter clinical trial involving patients with rheumatoid arthritis.
The data package indicates that the tocilizumab developed by Richter demonstrates results comparable to the reference product in terms of efficacy, drug safety, and immunogenicity for the studied population.
This complete data package forms the basis for the approval of biosimilar products across all therapeutic indications of the originator.
RGB-19 is part of Richter's ongoing collaboration with Mochida Pharmaceutical Co., Ltd. The submission of the biosimilar tocilizumab application to the EMA reflects Richter's commitment to establishing a diverse portfolio of affordable drug options.
The approval of biosimilars aims to ensure access to this critical biological therapy for a wide patient population in Europe.
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