FDA has recently approved rituximab-abbs as a biosimilar to Rituximab. It is designed for adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) and can be used as a single agent or in combination with chemotherapy. It is the first biosimilar to be approved for NHL. Data from two randomized, double-blinded trials were considered for the approval of rituximab-abbs.
With the approval of rituximab-abbs, now the FDA has approved 15 biosimilars. “A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity, and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law”. Rituximab-abbs is specified for the treatment in the…
