Hyderabad: The US Food and Drug Administration has approved Dr Reddy’s Laboratories’ rituximab biosimilar for the US market, the Hyderabad-based drug maker said on Saturday. The product is a biosimilar to Rituxan, a widely used monoclonal antibody therapy.Dr Reddy’s developed, manufactured and submitted the product for approval. The decision followed a recent FDA pre-license inspection at the company’s biologics manufacturing facility in Bachupally, Hyderabad, the company said.Dr Reddy’s said it has already entered into an agreement with Fresenius Kabi to exclusively commercialise the biosimilar in the US. However, the two companies did not disclose the timing of the launch or the financial terms.The approval expands its global biosimilars portfolio and will strengthen its biologics business in a key regulated market, Dr Reddy’s said.“The approval of the rituximab biosimilar reflects our capabilities in developing and manufacturing complex biologic medicines for global markets,” said Sridevi Khambhampaty, global head of biologics at Dr Reddy’s.Rituximab targets the CD20 antigen on B lymphocytes and is used to treat B-cell malignancies, including non-Hodgkin lymphoma and chronic lymphocytic leukaemia, as well as autoimmune conditions.In the US, rituximab is approved for indications including rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.Dr Reddy’s said the FDA approval was supported by analytical, non-clinical and clinical evidence showing the biosimilar is highly similar to the reference product, with no clinically meaningful differences in safety, purity or potency.The biosimilar has already been commercialised in India, the European Union, the United Kingdom and more than 25 emerging markets, and has received approval in Switzerland and Canada.
