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FDA approves rituximab-abbs for the treatment of adult patients with CD20-positive B-cell NHL
On 28 November 2018, rituximab-abbs (Truxima®), a monoclonal antibody biosimilar to rituximab, was approved as a biosimilar to rituximab (Rituxan®) by the US Food and Drug Administration (FDA). Truxima® was approved for three indications including relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non–Hodgkin’s lymphoma (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 single-agent maintenance therapy; and non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
The approval of rituximab-abbs (Truxima®), the first approved biosimilar to rituximab for the treatment of CD20-positive B-cell NHL, was based on a review of a comprehensive data package inclusive of foundational and extensive analytical characterization, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy, and safety data.
Following extensive product characterization, rituximab-abbs (Truxima®) was shown to be biosimilar to rituximab (Rituxan®), as demonstrated by no clinically meaningful differences in terms of safety, purity, and potency of rituximab-abbs (Truxima®) from the reference product rituximab (Rituxan®). This provided the basis for the FDA approval of rituximab-abb (Truxima®) as a biosimilar to rituximab (Rituxan®), and not as an interchangeable product.
According to the FDA, the biosimilar approval of rituximab-abbs (Truxima®) is the third biosimilar approval in the past month. A biosimilar is a biological product that is approved based on data that shows it is highly similar to a biological product already approved by the FDA, and this could expand patient access to important medicines.
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