Hyderabad, Jan 20 Dr. Reddy’s Laboratories 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.
Following successful completion of full set of clinical studies of proposed rituximab biosimilar candidate DRL_RI, Dr. Reddy’s will now prepare to file in the United States, European Union and other regions.
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.
It is being developed 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.
To file for license and marketing
Hyderabad -based Dr. Reddy’s rituximab biosimilar has already been approved for marketing in India and over 25 emerging markets. 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.
Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s, said: “This is a very important milestone in our biosimilars journey. The successful completion and positive outcome of these clinical studies highlights our capability for global clinical development of biosimilar products for highly regulated and global 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 othergeographies directly, according to a release.