INDIA – Dr. Reddy’s Laboratories has reached a key milestone on the path to commercialization of its rituximab biosimilar, DRL_RI, as the drug major successfully completed the full set of clinical studies of its biosimilar product.
Dr. Reddy’s announced that its proposed rituximab biosimilar candidate is set for filing in highly regulated markets such as the United States, Europe and beyond as a new potential treatment option for rare conditions.
In addition, the Hyderabad-based company is working closely with Fresenius Kabi, a European generic medicine manufacturer, to commercialise its proposed biosimilar of rituximab in the United States.
“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,” the company said in an official statement.
Upon regulatory approval, DRL_RI will be a safe and effective treatment option for adult patients with rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
The recent studies showed pharmacokinetic equivalence and similarity in pharmacodynamics, safety and immunogenicity between DRL_RI and EU reference medicinal product and U.S. reference product.
According to the company’s note, Dr. Reddy’s is now preparing to file Biologics License Application (BLA) / Marketing Authorisation Application (MAA) dossiers with global regulatory authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
“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,” the drug major underscored.
Furthermore, Dr. Reddy’s confirmed that it intends to commercialise the product in Europe and other geographies directly.
Dr. Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s, said: “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.”
He noted that the positive results underscores their commitment to developing high quality biosimilars and reinforces the potential of DRL_RI as a safe and effective treatment option to patients across the globe.
“This is a very important milestone in our biosimilars journey. Dr. Reddy’s biosimilars business is part of our key strategic initiatives expected to drive both near-term and future growth,” Dr. Jayanth Sridhar stated.