The FDA has approved the first rituximab (Rituxan) biosimilar, CT-P10 (Truxima; rituximab-abbs), for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) as a single agent or in combination with chemotherapy.1
This is the first biosimilar approved by the FDA for the treatment of patients with NHL.
CT-P10, which is developed by Celltrion and Teva Pharmaceutical Industries, has approved indications that are equivalent to reference rituximab, which includes: relapsed/refractory, low-grade or follicular lymphoma, CD20-positive B-cell NHL as a single agent; previously untreated follicular lymphoma, 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 single-agent maintenance therapy; and non-progressing or stable low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine and prednisone (CVP) chemotherapy.
"The Truxima approval is our third biosimilar approval in the past month," said Scott Gottlieb, MD, FDA Commissioner, in a press release. "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."
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