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Home » Celltrion and Teva’s Rituximab Biosimilar Gains FDA Approval
Celltrion and Teva’s Rituximab Biosimilar Gains FDA Approval
December 6, 2018
The FDA announced the first biosimilar of Roche’s blockbuster cancer drug Rituxan (rituximab) — approving Teva and Celltrion’s Truxima (rituximab-abbs) for treating non-Hodgkin’s lymphoma.
The 15th biosimilar to be cleared by the FDA, Truxima is approved for treating 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 a 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 (CVP) chemotherapy.
“We’re seeing more biosimilar drugs gain market share as this industry matures,” Commissioner Scott Gottlieb said in announcing the approval.
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