The biologics licence application of Dr. Reddy’s Laboratories for its proposed biosimilar rituximab candidate DRL_RI has been accepted for a review by the U.S. Food and Drug Administration (U.S. FDA).
It follows the acceptance of its rituximab biosimilar file for review by two different regulatory businesses – the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare merchandise Regulatory Agency (MHRA), the drugmaker stated on Wednesday.
DRL_RI is being developed as a biosimilar of Roche’s Rituxan / MabThera (rituximab), which is authorized for numerous indications, together with for remedy of grownup sufferers with rheumatoid arthritis, non-Hodgkin’s lymphoma and continual lymphocytic leukaemia.
In January, Dr. Reddy’s had introduced the profitable completion of the complete set of scientific research of the proposed rituximab biosimilar candidate for submitting in extremely regulated markets such because the U.S., EU and different areas. The submission of its file in April 2023 was primarily based on a complete knowledge package deal, it stated.
The rituximab biosimilar has been authorized for advertising and marketing in India and over 25 rising markets. The firm is presently collaborating with its accomplice Fresenius Kabi, a worldwide well being care firm, to commercialise the proposed biosimilar within the U.S. It intends to commercialise the product in Europe and different geographies straight, Dr. Reddy’s stated.
