Budapest, 15 January 2025 - Gedeon Richter („Richter”) announces today positive topline
results from Phase I and Phase III clinical studies for its proposed biosimilar to RoActemra®
tocilizumab – development code: RGB-19.
The 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.
“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.” said Dr. Erik Bogsch, Head of the Biotechnology Business Unit at Richter.
“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.” said Taiji
Hayano, Executive Managing Officer, Head of Clinical Research and Development Division at
Mochida.
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.
About Gedeon Richter
Gedeon Richter Plc. (www.gedeonrichter.com), headquartered in Budapest/Hungary, is a
major pharmaceutical company in Central Eastern Europe, with an expanding direct presence
in Western Europe, China, Latin America, and Australia. Having reached a market
capitalization of EUR 4.3bn (USD 4.7bn) by the end of 2023, Richter's consolidated sales were
approximately EUR 2.1bn (USD 2.3bn) during the same year. The product portfolio of Richter
covers many important therapeutic areas, including Women's Healthcare, Central Nervous
System, and Cardiovascular areas. Having the largest R&D unit in Central Eastern Europe,
Richter's original research activity focuses on CNS disorders. With its widely acknowledged
steroid chemistry expertise, Richter is a significant player in the Women's Healthcare field
worldwide. Richter is also active in biosimilar product development, manufacture and
commercialization.
About Mochida Pharmaceutical
Mochida Pharmaceutical Co., Ltd. (www.mochida.co.jp), headquartered in Tokyo/Japan, has
been committed to research and development of innovative pharmaceutical products since its
establishment in 1913 thereby providing distinctive medicines to the medical field. Currently,
the core pharmaceutical business focuses resources on the targeted areas of cardiovascular
medicine, obstetrics and gynecology, psychiatry and gastroenterology, while also providing
medicine for intractable disease as well as generics including biosimilars, to meet medical
needs.
For further information:
Investors: Róbert Réthy, CFA +36 20 342 2555
Media: Zsuzsa Beke +36 20 916 4507