Pharmaceutical major Dr. Reddy’s Laboratories on Friday announced that it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in markets such as the US, Europe, and other regions.
DRL_RI is being developed as a biosimilar of rituximab for various indications including the treatment of adult patients with rheumatoid arthritis, pemphigus vulgaris, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis.
Dr. Reddy’s rituximab biosimilar has already been approved for marketing in India and over 25 emerging markets.
Dr. Reddy’s has taken further clinical development to meet regulatory requirements of highly regulated markets such as the US, Europe, and other regions.
The pharma major is now preparing to file Biologics License Application (BLA)/Marketing Authorisation Application (MAA) dossiers with various regulatory authorities globally.
The company mentioned that the successful completion and positive outcome of these clinical studies highlight its capability for global clinical development of biosimilar products for highly regulated and global markets.
These results also underscore the potential of DRL_RI as a safe and effective treatment option for patients across the globe.
Dr. Reddy’s biosimilars business is part of the pharma major’s key strategic initiatives that are expected to drive both near-term and future growth.
The Hyderabad-based company this week announced that it significantly reduced the price of its cardiovascular drug Cidmus which has a market share of 32 percent. Following the price cut, Cidmus will be priced at Rs 29 for 50 mg, Rs 49 for 100 mg, and Rs 79 for 200 mg per tablet.
The company this month also acquired the trademark rights of the breast cancer drug PRIMCYV from Pfizer Products India for use in the Indian market.
Shares of Dr Reddy’s are trading 0.87 percent higher at Rs 4,370.
