The filing of the company’s dossier in April this year was based on the data package including pre-clinical and head-to-head clinical studies that show similarity in pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity with the EU and US reference products
DRL_RI has been developed as a biosimilar of rituximab for rheumatoid arthritis and others. (Credit: Towfiqu barbhuiya on Unsplash)
Dr. Reddy’s Laboratories has announced that the biologics license application (BLA) for its proposed biosimilar rituximab candidate DRL_RI has been accepted for review by the US Food and Drug Administration (FDA).
Recently, the rituximab biosimilar dossier was accepted for review by the European Medicines Agency (EMA) as well as the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
Rituxan/MabThera (rituximab) is a cluster of differentiation 20 (CD20) directed cytolytic antibodies.
The combination drug has approval for the treatment of adult patients with rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, pemphigus vulgaris, granulomatosis with polyangiitis, and microscopic polyangiitis.
Dr. Reddy’s biologics global head Jayanth Sridhar said: “This milestone underscores our capability for global clinical development of high-quality biosimilar products for highly regulated and global markets. It also reinforces the potential of DRL_RI as a safe and effective treatment option for patients across the globe.
“Development and commercialisation of biological drugs is an important growth lever for our business. We expect to bring many more biosimilar and other critical biological products to meet patient needs as we work towards our goal of serving over 1.5 billion patients by 2030.”
The Indian pharma company announced in January that DRL_RI had successfully finished the entire set of clinical studies for filing in the US, the European Union (EU), and other areas.
The filing of its dossier in April this year was based on the data package including pre-clinical and head-to-head clinical studies that show similarity in pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity with the EU and US reference products.
This data package also included robust structural and functional analytical comparison data using multiple orthogonal techniques, said Dr. Reddy’s.
More than 25 emerging nations as well as India have already given their approval for the marketing of Dr. Reddy’s rituximab biosimilar.
The pharmaceutical firm is now working with Fresenius Kabi to commercialise the proposed rituximab biosimilar in the US.