Pfizer Receives European Commission Approval for RUXIENCE™ (rituximab-pvvr), a Biosimilar to Rituxan/MabThera
Pfizer
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European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Compiled by Fan Dongdong
Pfizer Announces EU Approval of Ruxience (rituximab-pvvr), a Biosimilar to Rituximab (MabThera), for the Treatment of Non-Hodgkin Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Rheumatoid Arthritis (RA), Granulomatosis with Polyangiitis (GPA), Microscopic Polyangiitis (MPA), and Pemphigus Vulgaris (PV)
This approval is based on a comprehensive data package, including the results of the REFLECTIONS B3281006 comparative clinical study, which evaluated the efficacy, safety, and immunogenicity, as well as the pharmacokinetics and pharmacodynamics, of Ruxience. The results demonstrated that, in patients with CD20-positive, low tumor burden, there were no clinically significant differences between Ruxience and Rituxan in terms of safety and efficacy.
In the European Union, two rituximab biosimilars had previously been approved: Truxima from Teva and Celltrion, and Rixathon/Riximyo from Novartis Sandoz.
In the United States, in November 2018, Teva and Celltrion’s Truxima was approved, becoming the first rituximab biosimilar approved by the FDA. In July 2019, Ruxience received FDA approval, becoming the second rituximab biosimilar approved in the United States.
In China, in February 2019, the National Medical Products Administration approved the marketing registration application for Henlius' rituximab injection (brand name: Hanlikang) from Shanghai. This drug is the first biosimilar approved in China, primarily used for the treatment of non-Hodgkin lymphoma.
Masum Hossain, President of International Development Markets for Pfizer Oncology, stated: “Ruxience has demonstrated safety and efficacy comparable to those of MabThera, with the potential to improve patient treatment pathways while reducing healthcare costs. We look forward to making Ruxience available to patients in the European Union in the coming months.”
For many years, Rituxan (Rituximab), Herceptin (Trastuzumab), and Avastin (Bevacizumab) have been collectively known as Roche’s “three pillars” of blockbuster oncology drugs, consistently ranking at the top of domestic and international oncology drug sales charts. However, with the successive approval and market launch of biosimilars, their market positions will face severe challenges in the future.
Reference Source: Pfizer Receives European Approval for Oncology Biosimilar, RUXIENCE™ (rituximab)
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