First Biosimilar for Non-Hodgkin's Lymphoma Approved By FDA

Officials with the FDA have approved rituximab-abbs (Truxima, Celltrion) as a biosimilar to Rituxan (Genentech), making it the first biosimilar for the treatment of adult patients with non-Hodgkin’s lymphoma, according to a press release.

With this approval, the agency has now approved 15 biosimilars in the United States. Most recently, the FDA gave the green light to pegfilgrastim-cbqv (Udenyca) for patients with cancer receiving myelosuppressive chemotherapy. The drug is a biosimilar to Amgen’s pegfilgrastim (Neulasta).

Ritxumiab-abbs is indicated for the treatment of adults with:

• Relpased or refractory, low grade or follicular, CD20-positive B-cell 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 a single-agent maintenance therapy.
• Non-progressing (including stable disease), low-grade, CD20 positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy.

The approval is based on review of evidence including extensive structural and functional characterization, animal study data, human pharmacokinetic data, clinical immunogenicity data, and other clinical data. Rituximab-abbs has been approved as a biosimilar, not as an interchangeable product, according to the FDA.

Common adverse effects associated with rituximab-abbs include infusions, fever, lymphopenia, chills, infection, and weakness. The labeling for rituximab-abbs contains a Boxed Warning about the increased risks of fatal infusion reactions, severe skin and mouth reactions, hepatitis B virus reactivation, and Progressive Multifocal Leukoencephalopathy.

Six biosimilars have been approved by the FDA in 2018 thus far. The FDA’s Biosimilar Action Plan, released in July, aims to advance new policies designed to make the development of biosimilars more efficient and successful.

“The growing pipeline of biosimilars is encouraging,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “We’re seeing more biosimilar drugs gain market shares as this industry matures. 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.”

Reference

FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm627009.htm. Accessed November 28, 2018.