Biosimilars in the United States: Current Status and Future Implications

Biosimilars in the United States: Current Status and Future Implications

November 28, 2018
2 min read

FDA approves Truxima, first biosimilar for adults with non-Hodgkin lymphoma

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Scott Gottlieb
Scott Gottlieb

The FDA today approved rituximab-abbs as a single agent or in combination with chemotherapy for the treatment of adults with CD20-positive, B-cell non-Hodgkin lymphoma.

Rituximab-abbs (Truxima, Celltrion) is the first biosimilar to be approved in the U.S. for non-Hodgkin lymphoma and the first approved biosimilar to rituximab (Rituxan; Genentech, Biogen Idec).

The biosimilar is indicated for the treatment of adults with:

Relapsed or refractory, low-grade or follicular, CD20-positive B-cell non-Hodgkin lymphoma, as a single agent;

Previously untreated follicular, CD20-positive, B-cell non-Hodgkin lymphoma, 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

Nonprogressing, low-grade, CD20­positive B-cell non-Hodgkin lymphoma, as a single agent after first-line cyclophosphamide, vincristine and prednisone chemotherapy.

Biological products — generally large, complex molecules — may be produced through biotechnology in a living system, such as a microorganism, plant cell or animal cell.

This approval of rituximab-abbs is based on a review of evidence, which included extensive structural and functional characterization, animal study data, human pharmacokinetic data, clinical immunogenicity data, and other clinical data that demonstrates the agent is biosimilar to reference rituximab, according to the FDA.

Common adverse events associated with rituximab-abbs include infusion reactions, fever, lymphopenia and asthenia. Clinicians are advised to monitor patients for tumor lysis syndrome, cardiac adverse reactions, renal toxicity, and bowel obstruction and perforation.

The label for rituximab-abbs includes a boxed warning — like its reference product — that alerts health care providers and patients to increased risks for fatal infusion reactions, severe skin and mouth reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy.

This approval marks the FDA’s 15th approved biosimilar.

“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. Our goal is to promote competition that can expand patient access to important medicines,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “The Truxima approval is our third biosimilar approval in the past month. The growing pipeline of biosimilars is encouraging. We’re seeing more biosimilar drugs gain market share 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.”