Dr Reddy's rituximab biosimilar approved in US, already in 25+ global markets

For US hospitals and payers, biosimilar competition is a critical lever to rein in the cost of biologic drugs, which can exceed $50,000 per patient annually. The FDA’s green light for Dr Reddy’s rituximab copycat to Rituxan adds a new entrant to a market that could reduce spending on one of the world’s top-selling cancer therapies, potentially improving access for the nearly 900,000 Americans living with non-Hodgkin lymphoma.

Dr Reddy's Laboratories has secured USFDA approval for its rituximab biosimilar, a copycat version of Roche/Genentech's blockbuster monoclonal antibody Rituxan. The decision, announced on August 1, 2026, marks a significant milestone for the Hyderabad-based pharma company, allowing it to enter the highly competitive US biosimilar market with a therapy used to treat B-cell malignancies such as non-Hodgkin lymphoma and chronic lymphocytic leukaemia, as well as autoimmune conditions including rheumatoid arthritis and granulomatosis with polyangiitis. The approval is particularly notable as it follows a pre-license inspection at Dr Reddy's biologics manufacturing facility in Bachupally, Hyderabad, which the company passed successfully — a demonstration of its end-to-end development and manufacturing capabilities for complex biologics.

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For US hospitals and payers, biosimilar competition is a critical lever to rein in the cost of biologic drugs, which can exceed $50,000 per patient annually.

The rituximab biosimilar landscape is already crowded in the US, with multiple competitors from companies like Teva, Pfizer, and Amgen challenging Roche's dominant position. However, Dr Reddy's entry, supported by a commercialization deal with German healthcare group Fresenius Kabi, positions the partners to capture a meaningful share of an estimated $7 billion global rituximab market. Fresenius Kabi, which has a strong US hospital and infusion portfolio, will exclusively market and distribute the product. While the financial terms and launch timeline remain undisclosed, the partnership combines Dr Reddy's cost-effective development and manufacturing with Fresenius Kabi's established commercial infrastructure, creating a formidable competitive force.

The biosimilar has already been commercialized in India, the European Union, the United Kingdom, and over 25 emerging markets, and has received approvals in Switzerland and Canada. This global footprint underscores Dr Reddy's ability to navigate diverse regulatory frameworks and scale production. The FDA approval was supported by a comprehensive package of analytical, non-clinical, and clinical data demonstrating high similarity to the reference product with no clinically meaningful differences in safety, purity, or potency — the standard biosimilar pathway that avoids costly and time-consuming full clinical trials.

For US healthcare, biosimilars like this offer a critical opportunity to reduce drug spending. Biologics account for a disproportionate share of pharmaceutical costs, and rituximab alone generates billions in US sales. Patients with cancers and autoimmune diseases often face high out-of-pocket costs or limited access, so the introduction of a new biosimilar can drive price competition and improve affordability. Payers and hospital systems are increasingly adopting biosimilar-first policies, and Dr Reddy's product — backed by a well-known manufacturer and a major partner — is likely to see rapid uptake if priced competitively.