Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., Celltrion, Inc., and Celltrion Healthcare, Co., Ltd. announced that TRUXIMA® (rituximab-abbs) injection is the first biosimilar to the reference product Rituxan® (rituximab) now available in the United States with a full oncology label.
TRUXIMA is currently indicated for the treatment of adult patients with non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL):
- Non-Hodgkin’s Lymphoma (NHL)
- Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHLas 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
- Non-progressing (including stable disease), low-grade, CD20positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy
- Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens
- Chronic Lymphocytic Leukemia (CLL)
- In combination with fludarabine and cyclophosphamide (FC), for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL
“We are excited about the first FDA-approved biosimilar to rituximab in the U.S.,”
stated Brendan O’Grady, Executive Vice President and Head of North America Commercial at Teva.
“Teva’s commitment to biosimilars is focused on the potential to create lower healthcare costs and increased price competition. This focus is consistent with Teva’s mission of making accessible medications to help improve the lives of patients.”
TRUXIMA was approved by the U.S. Food and Drug Administration (FDA) as the first rituximab biosimilar. The approval was based on a review of a comprehensive data package inclusive of foundational and extensive analytical characterization, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy, and safety data. In May 2019, the FDA approved TRUXIMA to match all of the reference product’s oncology indications for NHL and CLL. In light of a patent settlement with Genentech, Celltrion and Teva have a pending FDA submission for rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA), and a license from Genentech to expand the TRUXIMA label to include these indications in Q2 2020.
“We are pleased to announce the launch of the first rituximab biosimilar, TRUXIMA, with our marketing partner Teva in the U.S.”
said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare.
“We believe that the introduction of TRUXIMA into the U.S. market will contribute to addressing the unmet needs of U.S. patients as well.”