FDA Grants Approval to First Biosimilar for Treatment of Non-Hodgkin's Lymphoma

Officials with the FDA have approved rituximab-abbs (Truxima, Celltrion) as a biosimilar to Rituxan (Genentech), making it the first biosimilar for the treatment of adult patients with non-Hodgkin’s lymphoma, according to a press release.

With this approval, the agency has now approved 15 biosimilars in the United States. Most recently, the FDA gave the green light to pegfilgrastim-cbqv (Udenyca) for patients with cancer receiving myelosuppressive chemotherapy. The drug is a biosimilar to Amgen’s pegfilgrastim (Neulasta).

Ritxumiab-abbs is indicated for the treatment of adults with:

• Relpased or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.
• 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 a single-agent maintenance therapy.
• Non-progressing (including stable disease), low-grade, CD20 positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy.

The approval is based on review of evidence including extensive structural and functional characterization, animal study data, human pharmacokinetic data, clinical immunogenicity data, and other clinical data. Rituximab-abbs has been approved as a biosimilar, not as an interchangeable product, according to the FDA.

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