FDA Approves Rituximab Biosimilar for Hematologic Malignancies

The FDA has approved a biosimilar for rituximab (Reditux) developed and manufactured by Dr. Reddy's Laboratories, referencing Rituxan (rituximab), for use in the treatment of select patients with hematologic malignancies.¹

The approval followed a Pre-License Inspection conducted by the FDA at Dr. Reddy's biologics manufacturing facility in Bachupally, Hyderabad, India, and was granted on the agency's goal date, according to the company. The FDA approval was supported by a body of analytical, nonclinical, and clinical evidence demonstrating that the biosimilar is highly similar to the reference product, with no clinically meaningful differences in safety, purity, and potency, consistent with FDA requirements for biosimilar approval.

“The approval of the rituximab biosimilar on the FDA's goal date reflects our capabilities in developing and manufacturing complex biologic medicines for global markets,” Sridevi Khambhampaty, global head of Biologics at Dr. Reddy's Laboratories, stated in the news release.

What are rituximab’s indications?

Rituximab is approved by the FDA across the following indications, according to its prescribing information²:

• for adult patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin lymphoma (NHL) as a single agent
• Adult patients with previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
• Adult patients with non-progressing, low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy.
• Adult patients with previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone or other anthracycline-based chemotherapy regimens.
• Pediatric patients aged 6 months and older with previously untreated, advanced-stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia in combination with chemotherapy.
• Adult patients with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia in combination with fludarabine and cyclophosphamide.

Rituximab also holds the following non-oncology indications:

• Adult patients with moderately to severely active rheumatoid arthritis in combination with methotrexate who have had an inadequate response to 1 or more TNF antagonist therapies.
• Adult and pediatric patients 2 years of age and older with granulomatosis with polyangiitis (Wegener granulomatosis) and microscopic polyangiitis in combination with glucocorticoids.
• Adult patients with moderate to severe pemphigus vulgaris.

What is the mechanism of action of rituximab?

Rituximab is a CD20-directed cytolytic monoclonal antibody that selectively targets the CD20 antigen expressed on the surface of B lymphocytes.² By binding to CD20, rituximab induces B-cell depletion through multiple immune-mediated mechanisms.

The agent is widely used in the treatment of several B-cell malignancies, including non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL), as well as certain autoimmune conditions.¹

What are the next steps for the rituximab biosimilar?

The rituximab biosimilar was developed, manufactured, and submitted for approval by Dr. Reddy's Laboratories. The product has already been commercialized in India, the European Union, the United Kingdom, and more than 25 emerging markets, and has received marketing approval in Switzerland and Canada.

The company noted that the approval reflects its capabilities in bringing complex biologic medicines to highly regulated markets. Dr. Reddy's launched its rituximab biosimilar in Europe in 2025 and markets a portfolio of biosimilar products across oncology and immunology, according to the release.

References

1. Dr. Reddy's Laboratories receives U.S. FDA approval for rituximab biosimilar. News release. Dr. Reddy's Laboratories. August 1, 2026. Accessed August 4, 2026. https://www.drreddys.com/cms/sites/default/files/2026-08/20260801_PressRelease_rituximab_SE.pdf
2. Rituxan. Prescribing information. Genentech. Updated December 2021. Accessed August 4, 2026. https://www.gene.com/download/pdf/rituxan_prescribing.pdf