Celltrion gets FDA clearance for biosimilar Truxima
The Food and Drug Administration has approved Celltrion’s Truxima (rituximab-abbs) as the first biosimilar to Genentech’s Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin's lymphoma, or NHL, to be used as a single agent or in combination with chemotherapy. Truxima is the first biosimiliar to be approved in the U.S. for the treatment of non-Hodgkin's lymphoma.
"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 said.
"The Truxima approval is our third biosimiliar 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," Gottlieb said.
Truxima is indicated for the treatment of adult patients with: relapsed 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 single-agent maintenance therapy; and non-progressing, including stable disease, low-grade, CD20 positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine and prednisone chemotherapy.
"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 said.
"The Truxima approval is our third biosimiliar 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," Gottlieb said.
Truxima is indicated for the treatment of adult patients with: relapsed 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 single-agent maintenance therapy; and non-progressing, including stable disease, low-grade, CD20 positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine and prednisone chemotherapy.