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.
- PFIZER RECEIVES EUROPEAN APPROVAL FOR ONCOLOGY BIOSIMILAR, RUXIENCE™ (RITUXIMAB). Published April 2, 2020. https://bit.ly/2XazlWi. Accessed April 2, 2020.
- 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.
- 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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