Teva Pharmaceuticals USA, a US affiliate of Teva Pharmaceutical announced that Truxima (rituximab-abbs) injection is now available in the United States for the treatment of rheumatoid arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies.
Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids.
Truxima is the only biosimilar to the reference product Rituxan (rituximab) available to treat rheumatoid arthritis in the United States. See important safety information below including Boxed Warning regarding fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy.
“We are proud to make Truxima available to patients and providers as a treatment option for these indications, especially as this is the only rituximab biosimilar indicated for rheumatoid arthritis,” said Brendan O’Grady, executive vice president, North America Commercial, Teva. “Following the launch of our other biosimilar earlier this year, we remain focused on our commitment to lower healthcare costs and increase price competition through the availability of biosimilars.”
Celltrion Healthcare and Teva Pharmaceutical Industries Ltd. entered into an exclusive partnership in October 2016 for Teva to commercialize Truxima in the US and Canada. In May 2019, Truxima was approved by the US Food and Drug Administration (FDA).
“We are pleased that patients in the United States can now have access to Truxima for these new indications,” said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. “We believe that the continued use of biosimilars in the US market will contribute to addressing unmet needs for patients and providers.”
Earlier this year, the Centers for Medicare and Medicaid Services (CMS) granted pass-through status for Truxima in the hospital outpatient setting. The Wholesale Acquisition Cost (WAC or “list price”) for Truxima will be 10 percent lower than the reference product. Truxima is expected to be available through primary wholesalers at a WAC of US$ 845.55 per 100mg vial and US$ 4,227.75 per 500mg vial. Actual costs to individual patients and providers for Truxima are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply. Savings on out-of-pocket costs may vary depending on the patient’s insurance payer and eligibility for participation in the assistance program.
Teva also offers dedicated patient support services through the CORE program. CORE is available to help eligible patients, caregivers and healthcare professionals navigate the reimbursement process. CORE offers a range of services, including benefits verification and coverage determination, support for precertification and prior authorization, assistance with coverage guidelines and claims investigation, and support through the claims and appeals process.
Truxima (rituximab-abbs) is a US Food and Drug Administration (FDA)-approved biosimilar to Rituxan (rituximab) for the treatment of: adult patients with CD20-positive, B-cell NHL to be used as a single agent or in combination with chemotherapy or CLL in combination with fludarabine and cyclophosphamide (FC); for rheumatoid arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies; and granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic polyangiitis (MPA) in adult patients in combination with glucocorticoids
Truxima has the same mechanism of action as Rituxan and has demonstrated biosimilarity to Rituxan through a totality of evidence.