Dr. Reddy's Proposed Rituximab Biosimilar Application Accepted for Review by USFDA, EMA and MHRA
17 July 2023 - - India-based pharmaceutical company Dr. Reddy's Laboratories Ltd. (BSE: 500124) (NSE: DRREDDY) (NYSE: RDY) (NSEIFSC: DRREDDY) said its Biologics License Application for its proposed biosimilar rituximab candidate DRL_RI has been accepted for a substantive review by the US Food and Drug Administration (USFDA).

This closely follows acceptance of its rituximab biosimilar dossier for review by two other regulatory agencies the European Medicines Agency and the United Kingdom's Medicines and Healthcare products Regulatory Agency.

In January 2023, Dr. Reddy's had announced the successful completion of the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, European Union, and other regions.

The submission of its dossier in April 2023 was based on a comprehensive data package including robust structural and functional analytical comparison data using multiple orthogonal techniques, pre-clinical, and head-to-head clinical studies that demonstrate similarity in pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity with the EU and US reference products.

DRL_RI is being developed as a biosimilar of Rituxan / MabThera (rituximab), a cluster of differentiation 20 directed cytolytic antibody.

Rituxan / MabThera is approved for various indications including for the treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.

Dr. Reddy's rituximab biosimilar has already been approved for marketing in India and over 25 emerging markets.

The company is currently collaborating with its partner Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, to commercialise its proposed biosimilar of rituximab in the United States.

The company intends to commercialise the product in Europe and other geographies directly.

Dr. Reddy's biosimilars business is part of our key strategic initiatives expected to drive both near-term and long-term growth.

Over the last 20 years, our Biologics team has developed into a fully integrated organisation with robust capabilities in the development, manufacture and commercialisation of a range of biosimilar products in oncology and immunology.

It has a current portfolio of six commercial products marketed in India and over 27 Emerging Markets.

In addition, we have several products in the pipeline in oncology and auto-immune diseases in various stages of development for global launches across regulated as well as emerging markets.

Recently, we announced the successful completion of Phase I study and initiation of Phase III study of DRL_TC, our proposed biosimilar of tocilizumab via both the subcutaneous and intravenous routes, for global markets.