Drugmaker Dr. Reddy’s Laboratories on Friday said it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate DRL_RI.
Completion of the studies takes it closer to filing in regulated markets such as the U.S., Europe and other regions.
The company is developing DRL_RI as a biosimilar of monoclonal antibody rituximab, which is used in the treatment of certain autoimmune diseases and cancer. Rheumatoid arthritis, non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia figure in the list. Dr. Reddy’s is collaborating with its partner Fresenius Kabi to commercialise the proposed biosimilar of rituximab in the U.S, while it intends to commercialise the product in Europe and other geographies directly.
The biosimilar has already been approved for marketing in India and over 25 emerging markets. Dr. Reddy’s said it undertook further clinical development to meet regulatory requirements of highly regulated markets. Following successful completion of the clinical studies, it is preparing to file Biologics License Application (BLA)/Marketing Authorisation Application (MAA) dossiers with various regulatory authorities globally, the company said in a release.
Global Head of Biologics at Dr. Reddy’s Jayanth Sridhar said the successful completion and positive outcome of the clinical studies highlighted the company’s capability for global clinical development of biosimilar products for highly regulated and global markets.
MabThera and Rituxan, both registered trademarks of pharma major Roche, were the reference products in the EU and the U.S. respectively in the studies.