Teva and Celltrion Launch TRUXIMA® (rituximab-abbs), the First Rituxan Biosimilar in the United States, Marking Full Erosion of Roche's Blockbuster Trio

Truxima is currently indicated for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL), specifically:

—Regarding NHL treatment: (1) As monotherapy for the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive B-cell NHL; (2) In combination with first-line chemotherapy for previously untreated patients with follicular, CD20-positive B-cell NHL, and as single-agent maintenance therapy for patients with follicular, CD20-positive B-cell NHL who have achieved complete or partial response following combination therapy with a rituximab product and chemotherapy; (3) As monotherapy for patients with low-grade, CD20-positive B-cell NHL whose disease has not progressed after first-line CVP chemotherapy (cyclophosphamide + vincristine + prednisone); (4) In combination with CHOP (cyclophosphamide + doxorubicin + vincristine + prednisone) or other anthracycline-based chemotherapy regimens for the treatment of previously untreated patients with diffuse large B-cell, CD20-positive NHL.

—In the treatment of CLL: In combination with fludarabine and cyclophosphamide (FC), for the treatment of adult patients with CD20-positive CLL who are treatment-naïve or previously treated.

In the United States, Truxima is the first rituximab biosimilar approved by the FDA, as well as the first biosimilar approved by the FDA for the treatment of non-Hodgkin lymphoma (NHL). Truxima received FDA approval in late November 2018. This approval was based on a comprehensive data package, including foundational and extensive analytical characterization, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy, and safety data. In May 2019, the FDA approved Truxima for all oncology indications of the reference product Rituxan for the treatment of NHL and chronic lymphocytic leukemia (CLL).

Pursuant to the patent settlement reached with Genentech, a Roche subsidiary, Teva and Celltrion currently hold an application awaiting submission to the U.S. FDA for the treatment of rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA), as well as a license from Genentech to expand the Truxima label in the second quarter of 2020 to include the aforementioned indications.

In terms of pricing, Truxima’s wholesale acquisition cost (WAC) is 10% lower than that of Roche’s brand-name Rituxan. The WAC for a 100 mg vial of Truxima is $845.55, and for a 500 mg vial, it is $4,227.75. However, the actual out-of-pocket costs for patients and providers are expected to be lower than the WAC.

According to the FDA Biosimilar Database, a total of 24 biosimilars have been approved by the FDA to date, including nine targeting Roche’s three blockbuster biologics: Avastin (2), Herceptin (5), and Rituxan (2).

This July, Amgen and Allergan announced the launch of Mvasi and Kanjinti in the U.S. market. These two drugs are the first biosimilars of Avastin and Herceptin, respectively, to enter the U.S. market, with prices 15% lower than Roche’s branded products. The market entry of Truxima, the Rituxan biosimilar developed by Teva/Celltrion, also marks the complete erosion of Roche’s three flagship biologic agents in the U.S. market.