Dr. Reddy’s Laboratories Ltd. on Friday announced that it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI.
It will be filed in highly regulated markets such as the United States, Europe, and other regions.
According to Dr. Reddy’s Laboratories, DRL_RI is being developed as a biosimilar of rituximab, a cluster of differentiation 20 (CD20) directed cytolytic antibody for approval in the United States, European Union and other regions for various indications including
treatment of adult patients with rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
“The company undertook further clinical development to meet regulatory requirements of highly regulated markets. With the successful completion of these clinical studies, Dr. Reddy’s is now preparing to file Biologics License Application (BLA) / Marketing Authorisation Application (MAA) dossiers with various regulatory authorities globally,” the company stated on Friday.
The company also informed that its rituximab biosimilar has already been approved for marketing in India and over 25 emerging
markets.
“This is a very important milestone in our biosimilars journey. The successful completion and positive outcome of these clinical studies highlight our capability for global clinical development of biosimilar products for highly regulated and global markets. These
results underscore our commitment to developing high-quality biosimilars and reinforce the potential of DRL_RI as a safe and effective treatment option to patients across the globe,” Dr. Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s, said in a statement.
Currently, Dr. Reddy’s is 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.