Teva and Celltrion Launch TRUXIMA (rituximab-abbs) in the U.S. as the First and Only Rituxan Biosimilar for Rheumatoid Arthritis

May 05, 2020 News /BioonBIOON/ -- Teva and its partner, the South Korean biopharmaceutical company Celltrion, recently announced jointly that Truxima (rituximab-abbs) is now available in the United States for the treatment of: (1) in combination with methotrexate (MTX), for the treatment of patients who have had an inadequate response to one or moreTumorModerate to Severe [Disease] with Inadequate Response to Tumor Necrosis Factor (TNF) Antagonist TherapyRheumatoid Arthritis(RA) adult patients; (2) in combination with glucocorticoids for the treatment of adult patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

Truxima is a biosimilar of Roche’s flagship biologic Rituxan (MabThera, generic name: rituximab)BiosimilarsIt is worth noting that,Truxima is the only one in the United States that can be used to treat classRheumatoid Arthritis(RA) RituxanBiosimilars。

Regarding 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.

Brendan O'Grady, Executive Vice President of Commercial Operations for Teva North America, stated, “We are proud to offer Truxima as a treatment option for these indications to patients and providers. Notably, Truxima is the onlyRheumatoid Arthritis(RA) rituximab biosimilar. Following the launch of our other biosimilars earlier this year, we remain committed to providingBiosimilarsto reduce healthcare costs and increase price competition.”

In the United States, Truxima received FDA approval in late November 2018 as a monotherapy or in combination with chemotherapy for the treatment of adult patients with CD20-positive B-cell non-Hodgkin lymphoma (NHL). In May 2019, Truxima was further approvedFDAApproved for all Rituxan indicationsTumorIndications.

Truxima is the first FDA-approved biosimilar of Rituxan, andFDAThe first biosimilar approved for the treatment of NHL.This drug is used to treatTumorThe indicated indication was launched in the United States in November 2019, becoming the first Rituxan to enter that market.Biosimilars, with the same full as RituxanTumoroff-label use, for the treatment of non-Hodgkin lymphoma (NHL) and chronic lymphocyticLeukemia(CLL) adult patients, specifically:

——In terms of NHL treatment:(1) As a monotherapy for the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive B-cell non-Hodgkin lymphoma (NHL); (2) In combination with first-line chemotherapy for previously untreated patients with follicular, CD20-positive B-cell NHL, and as monotherapy maintenance treatment for patients with follicular, CD20-positive B-cell NHL who have achieved complete or partial response to combination therapy with a rituximab product and chemotherapy; (3) As a 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 terms of CLL treatment:In combination with fludarabine and cyclophosphamide (FC) for the treatment of adult patients with CD20-positive chronic lymphocytic leukemia (CLL), both treatment-naïve and previously treated.

Hyung Ki Kim, Vice Chairman of Celltrion Healthcare, stated, “We are pleased that patients in the United States can now access Truxima for these new indications. We believe that the continued use ofBiosimilarswill help address the unmet needs of patients and providers.”

Upon inquiry in the United StatesFDABiosimilar Database, with a total of 26 as of nowBiosimilarsObtainedFDAApproved, among whichNine biosimilars targeting Roche’s three flagship biologics: Herceptin (5), Avastin (2), and Rituxan (2).

Based on publicly available information, the nine [items/products/candidates] targeting Roche’s three flagship biologic agentsBiosimilarsinAll have been marketed in the United States:

——5 vials of HerceptinBiosimilars：Amgen/Allergan Kanjinti (launched in July 2019), Mylan/Biocon Ogivri (launched in December 2019),PfizerTrazimera (launched in February 2020), Teva/Celltrion’s Herzuma (launched in March 2020), and Merck/Samsung Biologics’ Ontruzant (April 2020).

—2 vials of AvastinBiosimilars：Amgen/Allergan’s Mvasi (launched in July 2019), Pfizer’s Zirabev (launched on December 31, 2019).

—2 doses of RituximabBiosimilars：Teva/Celltrion's Truxima (TumorThe indication was launched in November 2019, inflammation &Autoimmunityfor oncology indications in May 2020), and Pfizer’s Ruxience (rituximab, MabThera, launched on January 23, 2020). (Bioon.com)

Original Source: Teva and Celltrion Healthcare Announce the Launch of TRUXIMA (rituximab-abbs) Injection for Rheumatoid Arthritis, the Only Biosimilar to Rituxan (rituximab) Available in the United States for This Indication