28 November 2018 - The agency has now approved 15 biosimilars and is advancing new policies to improve the efficiency of biosimilar development and review.

The U.S. FDA today approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma to be used as a single agent or in combination with chemotherapy. Truxima is the first biosimiliar to be approved in the U.S. for the treatment of non-Hodgkin’s lymphoma.

The FDA’s approval of Truxima is based on a review of evidence that included extensive structural and functional characterisation, animal study data, human pharmacokinetic data, clinical immunogenicity data, and other clinical data that demonstrates Truxima is biosimilar to Rituxan. Truxima has been approved as a biosimilar, not as an interchangeable product.

Read FDA press release