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Rituximab Biosimilar Ruxience Approved in Europe

Jason M. Broderick @jasoncology
Published: Thursday, Apr 02, 2020

Igor Aurer, MD, PhD, professor of Medicine and Head of Hematology Division, University Hospital Centre Zagreb, Croatia

Igor Aurer, MD, PhD

The European Commission (EC) has approved the rituximab (Rituxan, US; MabThera, EU) biosimilar Ruxience (PF-05280586) for the treatment of patients with non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis, granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and pemphigus vulgaris.1

In the United States, PF-05280586 was introduced to the US market in January 2020 and was launched at a WAC of .68 per 10 mg, which translates to a 24% discount to the WAC of the reference product.

References           

  1. PFIZER RECEIVES EUROPEAN APPROVAL FOR ONCOLOGY BIOSIMILAR, RUXIENCE™ (RITUXIMAB). Published April 2, 2020. https://bit.ly/2XazlWi. Accessed April 2, 2020.            
  2. Sharman J, Liberati A, Silva R, et al. A randomized, double-blind efficacy and safety study of PF-05280586 (a potential rituximab biosimilar) compared with rituximab reference product (MabThera) in subjects with previously untreated CD20-positive, low tumor burden follicular lymphoma (LTB-FL). Presented at: 2018 ASH Annual Meeting; December 1-4, 2018; San Diego, CA. Abstract 394.
  3. Sharman JP, Liberati AM, Ishizawa K, et al. A randomized, double-blind, efficacy and safety study of PF-05280586 (a rituximab biosimilar) compared with rituximab reference product (MabThera®) in subjects with previously untreated CD20-positive, low-tumor-burden follicular lymphoma (LTB-FL) [published online ahead of print December 9, 2019]. BioDrugs. doi: 10.1007/s40259-019-00398-7

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