The U.S. Food and Drug Administration 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 (NHL) to be used as a single agent or in combination with chemotherapy.
Truxima is the first biosimilar to be approved in the US for the treatment of non-Hodgkin's lymphoma. "As part of the FDA's Biosimilars Action Plan, we are 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 access to important medicines," said FDA Commissioner Scott Gottlieb, MD.
"We are seeing more biosimilar drugs gain market share as this industry matures. We will continue to make sure biosimilar medications are passed through a process that makes certain that these new medicines meet the FDA's rigorous standards for approval," said Gottlieb.
Truxima is indicated for the treatment of adult patients with:
1. Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent;
2. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and
3. Non-progressing (including stable disease), low-grade, CD20 positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine and prednisone (CVP) chemotherapy.
Biological products are generally large, complex molecules and may be produced through biotechnology in a living system, such as a microorganism, plant cell or animal cell.
A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity and potency (ie, safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.
The FDA's approval of Truxima is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic data, clinical immunogenicity data, and other clinical data that demonstrate Truxima is biosimilar to Rituxan.
Truxas has been approved as a biosimilar, not as an interchangeable product. The most common side effects of Trux are infusion reactions, fever, abnormally low level of lymphocytes in the blood (lymphopenia), chills, infection and weakness (asthenia).
Health care providers are advised to monitor patients for tumor lysis syndrome (a complication of treatment where tumor cells are killed at the same time and released into the bloodstream), cardiac adverse reactions, damage to kidneys (renal toxicity), and bowel obstruction and perforation Patients should not receive vaccinations while in treatment.