Dr Reddy's labs completes clinical studies of Rituximab biosimilar for filing in US, Europe
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.
Hyderabad: Dr. Reddy’s Laboratories Ltd., a global pharmaceutical company, has 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.
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.
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.
Dr. 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. 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.”
Read also: Tocilizumab biosimilar met primary, secondary endpoints in Phase 1 study: Dr Reddy's Labs
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.
Read also: Dr Reddy's Labs acquires trademark rights of breast cancer drug from Pfizer
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.