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.