Dr. Reddy’s Takes Giant Leap Forward With Completion of Clinical Studies for U.S. and European Submission of Rituximab Biosimilar

Dr. Reddy’s Laboratories Ltd., a world-leading pharmaceutical company, has achieved a major milestone with the successful completion of all clinical trials for its proposed rituximab biosimilar candidate, DRL_RI. This groundbreaking development brings the company one step closer to filing in highly regulated markets such as the United States, Europe and other regions.

DRL_RI is an exciting biosimilar of the powerful CD20 directed cytolytic antibody rituximab that is being developed for approval in the US, EU and other regions. This groundbreaking treatment has the potential to revolutionize the treatment of various conditions such as rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis in adult patients.

Dr. Reddy’s rituximab biosimilar has already been approved for sale in India and numerous other emerging markets, and the company is now taking the next step to make it available in highly-regulated markets. Following successful clinical trials, the company is now in the process of filing Biologics License Application (BLA) and Marketing Authorisation Application (MAA) dossiers with various regulatory bodies, making the medication available to an even wider audience.

Dr. Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s, is celebrating a major milestone in their biosimilars journey. The successful completion and positive outcome of their clinical studies is a testament to their capability for global clinical development of biosimilars and reinforces their commitment to developing high-quality products for highly regulated and global markets. These results give hope that DRL_RI could be a safe and effective treatment option for patients across the globe.

Dr. Reddy’s is taking a major step forward in the healthcare industry by collaborating with its partner Fresenius Kabi to bring a proposed biosimilar of rituximab to the US market. Not only that, the company is also planning to commercialise the product in Europe and other geographies, marking an exciting milestone in the company’s mission to revolutionize modern healthcare.

About Dr. Reddy’s biosimilars programme:

Dr. Reddy’s biosimilar business has been a key strategic initiative, driving growth in both the near and long term. Over the past two decades, our Biologics team has developed a fully integrated organisation with strong capabilities in developing, manufacturing and commercialising a range of biosimilar products in oncology and immunology. Currently, we offer six commercial products in India and over 25 emerging markets, with several more in the pipeline for global launches across both regulated and emerging markets. We recently announced the successful completion of a Phase I study and the initiation of a Phase III study of DRL_TC, our proposed biosimilar of tocilizumab. We are also ramping up our manufacturing capacity to support our global expansion plans.

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