Data from Pharmawand - Curated by EPG Health - Date added 10 November 2019

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).

Truxima was approved by the 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.The Wholesale Acquisition Cost (WAC or “list price”) for Truxima will be 10 percent lower than the reference product.

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