Richter Announces Positive Topline Results for RGB-19

Gedeon Richter has announced positive topline results from Phase I and Phase III clinical studies for its proposed biosimilar to RoActemra® tocilizumab that has the development code 'RGB-19'.

The Hungarian pharmaceutical firm points out in a statement on the webiste of the Budapest Stock Exchange that Phase I clinical study evaluated the equivalence of pharmacokinetics between RGB-19 and the reference biologic in healthy adult males. The Phase III clinical study was a multicenter efficacy and safety comparability study in patients with rheumatoid arthritis. Both studies met their endpoints demonstrating clinical similarity between RGB-19 and the reference biologic.

RGB-19 has been developed jointly by Richter and Mochida Pharmaceutical Co., Ltd. (“Mochida”) and both clinical studies were conducted in Japan. Based on the results of the studies Richter expects to file for marketing authorization applications for RGB-19 in major European markets in the coming months, while Mochida expects to file for marketing authorization application for RGB-19 in Japan.

According to Dr. Erik Bogsch, Head of the Biotechnology Business Unit at Richter, “these clinical results, a proof of our successful collaboration with our highly respected partner, Mochida, underline the capability of our dedicated biotechnology platform. Our tocilizumab biosimilar is yet another important step in broadening our commercial portfolio and upon approval it would further strengthen our offering of affordable medicines to a wide range of patients worldwide.”

Taiji Hayano, Executive Managing Officer, Head of Clinical Research and Development Division at Mochida states that “it is our pleasure to announce the successful development of RGB-19 in collaboration with Richter. We have obtained positive results from clinical trials and believe that obtaining approval and launching RGB-19 will contribute to improving the quality of life for patients with rheumatoid arthritis and other conditions, as well as reducing their financial burden.”

Tocilizumab, the first biologic to inhibit IL-6 signaling, is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, cytokine release syndrome and COVID-19. The results of the studies will be used to support all indications for tocilizumab biosimilar RGB-19 based on extrapolation, the statement concludes.