FDA approves Reditux as rituximab biosimilar for B-cell malignancies and autoimmune diseases
- nuaxia
- Aug 6
- 2 min read
The approval adds another US biosimilar option for rituximab-treated conditions, including non-Hodgkin lymphoma and chronic lymphocytic leukaemia, although commercial availability and pricing have not yet been confirmed.
The US Food and Drug Administration has approved Reditux, Dr. Reddy’s Laboratories’ rituximab biosimilar referencing Rituxan, for the reference product’s eligible haematological malignancy and autoimmune disease indications.
The approval expands the number of rituximab biosimilars available to US clinicians and patients, with Fresenius Kabi holding exclusive US commercialisation rights.
Field | Content |
Alert Type | Drug Approval |
Drug Name | Reditux (rituximab biosimilar) |
Indication | Eligible indications of the reference product Rituxan, including CD20-positive non-Hodgkin lymphoma, CD20-positive chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris. |
Therapy Area(s) | Haematology; Oncology; Rheumatology; Immunology |
Geography | United States (FDA) |
What Happened | On 1 August 2026, the FDA approved Reditux, Dr. Reddy's Laboratories' rituximab biosimilar referencing Rituxan. The approval was supported by analytical, non-clinical and clinical evidence demonstrating no clinically meaningful differences from the reference product in terms of safety, purity and potency. Fresenius Kabi holds exclusive commercialisation rights for the product in the United States. |
Why It Matters | The approval provides healthcare providers with another rituximab biosimilar across multiple oncology and autoimmune indications, potentially increasing treatment choice and supporting biosimilar competition. However, FDA approval alone does not determine pricing, reimbursement, formulary inclusion or uptake in clinical practice. |
Supporting Context | Rituximab is a CD20-directed monoclonal antibody widely used in B-cell malignancies and several autoimmune diseases. Reditux has previously been marketed in India and approved in numerous international markets before receiving FDA approval. |
Key Takeaway | FDA approval adds another rituximab biosimilar to the US market, expanding treatment options across approved oncology and autoimmune indications. |
What to Watch | Commercial launch timing, payer coverage, formulary adoption and pricing will determine how quickly Reditux becomes available to US clinicians and patients. |
Primary Source | |
Relevant Date | 1 August 2026 |
Discover how nuaxia can support your next medical education initiative:
Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector
Contact us on: support@nuaxia.com
Comments