Dr. Reddy′s Laboratories Ltd. declared on Friday that its proposed rituximab biosimilar candidate, DRL _RI, has completed the entire set of clinical investigations.

It will be filed in countries with highly regulated markets, including Europe, the United States, and other areas.

DRL_RI is being developed as a biosimilar to rituximab, a cluster of differentiation 20 (CD20) directed cytolytic antibody, for regulatory approval in the US, EU, and other regions for several indications, including the treatment of adult patients with rheumatoid arthritis, non-lymphoma, Hodgkin′s chronic lymphocytic leukaemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.

In order to satisfy the regulatory criteria of highly regulated markets, the business claimed on Friday that it had undertaken further clinical development. Dr. Reddy′s is getting ready to submit Biologics License Application (BLA) / Marketing Authorization Application (MAA) dossiers with various regulatory agencies worldwide following the successful conclusion of these clinical studies.

The company also disclosed that over 25 emerging markets, including India, have already approved the sale of its rituximab biosimilar. The projected rituximab biosimilar being developed by Dr. Reddy′s and its partner Fresenius Kabi is now being commercialized in the United States. The company plans to directly market the product in Europe and other regions.

(Source: https://www.financialexpress.com/healthcare/pharma-healthcare/dr-reddys-completes-clinical-studies-of-its-biosimilar-for-autoimmune-disease/2954605/)