India’s largest generics drugmaker Dr. Reddy's Laboratories said it would develop a biosimilar of Roche’s MabThera (ingredient: rituximab). The Indian company plans to conduct a phase-3 study on the biosimilar in Korea via clinical research service provider Parexel.
The Ministry of Food and Drug Safety on Wednesday approved the phase-3 trial on DRL_RI, the biosimilar of rituximab.
Rituximab is used for lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.
Dr. Reddy’s is a multinational generics company based in India. The upcoming global phase-3 study will test the drug in patients with follicular lymphoma, in comparison with the efficacy, safety, and immunogenicity of the original medicine, MabThera.
The global trial will recruit 284 patients, including 26 Koreans. Patients eligible for the study are those with stage II-IV, cluster of differentiation (CD) 20 positive, and follicular lymphoma who have not been previously treated and have low tumor burden.
Drugmakers have already released biosimilars of MabThera in the market.
Local biosimilar maker Celltrion obtained the license for Truxima, a biosimilar of MabThera, from the U.S. Food and Drug Administration in 2018 and from the Canadian health authorities this year. Celltrion is reportedly to release the biosimilar in the U.S. within this year.
Another generics maker Sandoz also developed a rituximab biosimilar, called Rixathon. In July, Pfizer won the FDA nod to sell Ruxience, another rituximab biosimilar.
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