Dr. Reddy’s Proposed Biosimilar to Rituximab Gains Momentum with USFDA, EMA and MHRA Review!

Dr. Reddy’s, a renowned global pharmaceutical firm has recently made a quantum leap forward in advancing its proposed biosimilar rituximab candidate DRL_RI, with the U.S. Food and Drug Administration (USFDA) accepting its Biologics License Application (BLA) for a substantive review.

This noteworthy move is further bolstered by the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) also accepting the rituximab biosimilar dossier for review. An exciting period lies ahead for Dr. Reddy’s and this substantial progress serves as evidence of their commitment to revolutionizing the industry.

In April 2023, Dr. Reddy’s successfully filed its rituximab biosimilar candidate, DRL_RI, for approval in highly regulated markets such as the United States, European Union, and other regions. The comprehensive application included a comprehensive data package based on structural and functional analytical comparison, along with pre-clinical and clinical studies that demonstrate the drug’s similarities to the standard US and EU references in terms of pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity.

DRL_RI is set to revolutionize the world of medicine with its development as a biosimilar of Rituxan® / MabThera® (rituximab). This cluster of differentiation 20 (CD20) directed cytolytic antibody has been approved for various vital uses, including the treatment of adult patients with rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis. With DRL_RI’s potential to help those suffering from these conditions, it is a true game-changer in the field of biomedicine.

Dr. Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s, is thrilled to announce that DRL_RI has reached yet another milestone, emphasizing Dr. Reddy’s capability to develop high-quality biosimilars for regulated and global markets.

This further cements DRL_RI as a viable treatment option to improve the lives of numerous patients around the globe. Dr. Reddy’s is striving to fulfill their goal of providing essential medicinal care to 1.5 billion patients by 2030, and this is another step towards achieving that aim.

Dr. Reddy’s rituximab biosimilar has already been approved for marketing in India and over 25 other countries, and the company is partnering with Fresenius Kabi to bring it to the U.S. market. Fresenius Kabi is a global healthcare provider, specialized in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions. Dr. Reddy’s aims to expand their reach, bringing this lifesaving treatment to more countries across Europe and beyond.

About Dr. Reddy’s biosimilars programme:

Over the past two decades, Dr. Reddy’s has built up an integrated organisation with strong capabilities in the creation, production, and dissemination of biosimilar drugs for oncology and immunology treatments. Their current portfolio includes six products operating in India and over 27 Emerging Markets, with more in the pipeline, ranging from oncology to autoimmune diseases, for use in both regulated and non-regulated regions.

Recently, their proposed tocilizumab biosimilar, DRL_TC, successfully completed Phase I and began Phase III trials for global launch. Additionally, the organisation is revving up production capacity to support their world-spanning ambitions.

Dr. Reddy’s Laboratories Ltd., a global pharmaceutical company founded in Hyderabad, India in 1984, is devoted to providing access to cost-effective and progressive medications. Our wide selection of products and services range from APIs, generics, branded generics, biosimilars and OTC, and our therapeutic areas of focus include gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology.

With a pledge of ‘Good Health Can’t Wait’, our services are available in the United States, India, Russia & CIS countries, China, Brazil, and Europe. We are dedicated to setting the bar high in environmental stewardship; access and affordability for patients; diversity; and governance, as exhibited through our initiative to publish our first Sustainability Report in 2004.

Leave a Comment