The US Food and Drug Administration (FDA) has approved rituximab-abbs (Truxima, Celltrion Healthcare) for the treatment of adult patients with non-Hodgkin’s lymphoma. This indication stands as the first FDA-approved biosimilar for the rare blood cancer.
Specifically, rituximab-abbs is indicated for adult patients with “relapsed or refractory, low grade or follicular, CD20-positive B-cell non-Hodgkin’s lymphoma as a single agent; previously untreated follicular, CD20-positive, B-cell non-Hodgkin’s 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 non-progressing (including stable disease), low-grade, CD20 positive, B-cell non-Hodgkin’s lymphoma as a single agent after first-line cyclophosphamide, vincristine and prednisone (CVP) chemotherapy.”
Data on extensive structural and functional characterization, animal study, human pharmacokinetics, clinical immunogenicity, and other clinical data that demonstrates rituximab-abbs is biosimilar to Rituxan served as the basis for the approval.
The FDA notes it is important to recognize rituximab-abbs has not been approved as an interchangeable product but as a biosimilar.
Speaking on the FDA’s strides towards advancing biosimilar treatments, FDA Commissioner Scott Gottlieb, MD, said, “The rituximab-abbs 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.”
“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," he continued. "Our goal is to promote competition that can expand patient access to important medicines.”
Infusion reactions, fever, abnormally low level of lymphocytes in the blood (lymphopenia), chills, infection, and weakness (asthenia) include the most common side effects of rituximab-abbs.
Tumor lysis syndrome (a complication of treatment where tumor cells are killed off at the same time and released into the bloodstream), cardiac adverse reactions, damage to kidneys (renal toxicity), and bowel obstruction and perforation are to be monitored for in patients using rituximab-abbs.
Boxed warnings include fatal infusion reactions, severe skin and mouth reactions, some with fatal outcomes; hepatitis B virus reactivation, that may cause serious liver problems including liver failure and death; and progressive multifocal leukoencephalopathy.
Vaccinations should not be received by patients while administered rituximab-abbs treatment, and pregnant or breastfeeding women should not take rituximab-abbs since it may harm a developing fetus or newborn baby.