On Wednesday, Dr. Reddy’s Laboratories announced that the US Food and Drug Administration (USFDA) had accepted its biologics license application for its proposed biosimilar rituximab candidate for a substantive evaluation.
The United States Food and Drug Administration (USFDA) is a federal organization tasked with preserving and advancing public health through the regulation and oversight of food safety, tobacco, caffeine, dietary supplements, biopharmaceuticals, blood transfusions, prescription and over-the-counter pharmaceutical drugs (medications), electromagnetic radiation emitting devices (ERED), cosmetics, vaccines, medical devices, animal foods & feed, and veterinary products.
When a medicine is approved by the FDA, it implies that CDER has analyzed the drug’s effect data and found that for the intended population, the benefits of the drug outweigh any known or prospective dangers. The procedure for approving new drugs is organized into a clear framework.
This announcement from the company was made shortly after the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) accepted the rituximab biosimilar dossier for examination.
What is Rituximab
Rituximab is used to treat some cancers and autoimmune disorders. The FDA initially authorized this anti-CD20 monoclonal antibody in 1997. The FDA has approved its usage in the treatment of Pemphigus vulgaris, Microscopic Polyangiitis (MP), Chronic Lymphocytic Leukemia, Rheumatoid Arthritis, and B-cell Non-Hodgkin’s Lymphoma (CD20 positive).
Rituximab Program by Dr. Reddy
Dr. Reddy’s declared in January 2024 that their proposed rituximab biosimilar candidate, DRL_RI, had successfully finished the entire set of clinical studies in preparation for filing in highly regulated markets like the US, the EU, and other areas.
Pre-clinical and head-to-head clinical studies that show similarity in pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity with the EU and U.S. reference products were used to support the submission of its dossier in April 2024. This data package also included robust structural and functional analytical comparison data using multiple orthogonal techniques.
Rituxan® / MabThera® (rituximab), a cluster of differentiation 20 (CD20) directed cytolytic antibody, is being developed, while DRL_RI is being developed as a biosimilar. The treatment of adult patients with rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis, and microscopic polyangiitis are only a few of the treatments for which Rituxan® / MabThera® is licensed.
Dr. Reddy’s worldwide Head of Biologics Jayanth Sridhar stated that this milestone highlights the company’s capability for clinical development of high-quality biosimilar products in a global scale for highly regulated and global markets. It also confirms the product’s potential to be a secure and efficient treatment choice for people everywhere, he continued. According to Sridhar, the development and commercialization of biological pharmaceuticals is a key growth lever for the company’s operations.
Biosimilar Plans of Dr. Reddy’s
Dr. Reddy’s biosimilars business is one of the major strategic projects that will fuel both short-term and long-term growth. Their biologics team has evolved over the past 20 years into a fully integrated business with strong skills in the development, production, and commercialization of a variety of biosimilar products in the fields of oncology and immunology.
At present, the company sells six commercial goods in India and over 27 other emerging markets. Moreover, a number of oncology and auto-immune disease treatments are currently in various phases of development that will be launched globally. As the company move towards our objective of servicing more than 1.5 billion patients by 2030. Sridhar expects that Dr. Reddy’s will bring many more biosimilar and other critical biological products to meet patient needs.
More than 25 emerging nations, including India, have already given their approval for the commercialization of Dr Reddy’s rituximab biosimilar. In order to commercialize the planned rituximab biosimilar in the US, the company is now working with Fresenius Kabi, a worldwide healthcare corporation that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic medications for critical and chronic illnesses. The Hyderabad-based company said it planned to directly market the device in Europe and other regions.
