FDA Approves Rituximab Biosimilar Commercialized in US by Fresenius Kabi

Editor’s Take: Available biosimilars can expand patient access to high-quality and affordable biologics in the United States and elsewhere.

The U.S. FDA approved a rituximab biosimilar developed by Dr. Reddy’s Laboratories, commercialized in the U.S. exclusively by Fresenius Kabi.

The biosimilar references Rituxan, a Genentech–Biogen product. In general terms, rituximab is a monoclonal antibody targeting the CD20 antigen expressed on B lymphocytes. It sees wide usage in treatment of adults with B-cell malignancies such as non-Hodgkin lymphoma and chronic lymphocytic leukemia. Rituximab can also treat certain autoimmune conditions.

Other approved indications for rituximab in the United States include rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

Fresenius Biosimilar in Context

Fresenius Kabi says the approval is a step forward in its goal to strengthen a growing portfolio of biosimilars. The company holds exclusive rights to commercialize this particular biosimilar in the U.S. Dr. Reddy’s Laboratories previously developed, manufactured, and submitted it for approval.

Sang-Jin Pak, MD, Fresenius Kabi President, Biopharma, called it a “well-established molecule that strategically complements our oncology and immunology portfolios.”

“This reinforces our commitment to expanding patient access to high-quality, affordable biologic medicines in the U.S. market,” Pak said.

Built with FDA Approval in Mind

The biosimilar development program established in the agreement between Fresenius and Dr. Reddy’s was designed with FDA requirements in mind. Stipulations included high similarity to the reference product demonstrated through a series of comprehensive analytical, pharmacokinetic, clinical, and nonclinical studies.

To that end, the FDA found no clinically meaningful differences from Rituxan, the reference product.

For Fresenius’ part, the approval is another brick in the construction of a vertically integrated, end-to-end biopharma business. The company hopes to connect points along the entire value chain, from R&D to manufacturing to global commercialization.