Dr. Reddy’s successfully completes full set of clinical studies of its rituximab biosimilar for filing in the U.S. and Europe
Dr. Reddy’s Laboratories Ltd. announced that it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, Europe and other regions
The company undertook further clinical development to meet regulatory requirements of highly regulated markets. Dr. Reddy’s is currently collaborating with its partner Fresenius Kabi to commercialise its proposed biosimilar of rituximab in the United States. The company intends to commercialise the product in Europe and other geographies directly.
About Dr. Reddy’s clinical studies for its proposed biosimilar of rituximab, DRL_RI: 1. RI-01-003: This study demonstrated pharmacokinetic equivalence and similarity in pharmacodynamics, safety and immunogenicity between DRL_RI and EU reference medicinal product (MabThera)and U.S. reference product (Rituxan). 2. RI-01-006 (FLINTER): This study demonstrated efficacy equivalence and similarity in safety and immunogenicity between DRL_RI and EU reference medicinal product in patients with Low Tumour Burden Follicular Lymphoma .3. RI-01-007: This study demonstrated similar safety and immunogenicity profile between the DRL_RI, EU reference medicinal product and U.S. reference product groups upon single transition from either of them, in subjects with active rheumatoid arthritis.
The MabThera and Rituxan patents have expired.
Dr. Reddy’s rituximab biosimilar has already been approved for marketing in India and over 25 emerging markets.
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