First Biosimilar for Rituximab Gains Approval

The FDA approved rituximab-abbs, the first biosimilar of rituximab, for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL). This marks the first biosimilar approved for NHL and the 15th biosimilar approved for use in the U.S.

“As part of the FDA’s Biosimilars Action Plan, we’re advancing new policies to make the development of biosimilars more efficient and to enable more opportunities for biosimilar manufacturers to make these products commercially successful and competitive,” said FDA Commissioner Scott Gottlieb, MD. “We’ll continue to make sure biosimilar medications are evaluated efficiently through a process that makes certain that these new medicines meet the FDA’s rigorous standards for approval.”

The indication for rituximab-abbs covers the indications of its reference product, including: patients with previously untreated, CD20-positive follicular lymphoma (in combination with first-line chemotherapy); patients achieving a CR or PR to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and patients with non-progressing, low-grade, CD20­positive, B-cell NHL (as a single agent after first-line cyclophosphamide, vincristine, prednisone chemotherapy).

The FDA’s approval of rituximab-abbs was based on a review of the agent’s structural and functional characteristics, animal study data, human pharmacokinetic data, clinical immunogenicity data, and other clinical data that demonstrated the agent was biosimilar to rituximab.

Rituximab-abbs was approved as a biosimilar – not an interchangeable – product.

The most common AEs associated with rituximab-abbs included infusion reactions, fever, lymphopenia, chills, infection, and asthenia. The FDA’s approval letter advised health-care providers to monitor patients for tumor lysis syndrome, cardiac adverse reactions, renal toxicity, and bowel obstruction and perforation.

Like its reference product, rituximab-abbs carries a boxed warning for increased risks of the following: fatal infusion reactions, severe skin and mouth reactions, hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy.

Source: FDA news release, November 28, 2018.