Pfizer receives European approval for Oncology Biosimilar, RUXIENCE (rituximab)

New York: Pfizer Inc. has announced that the European Commission (EC) has approved RUXIENCE™ (rituximab), a monoclonal antibody (mAb) and biosimilar to MabThera® (rituximab), for the treatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and pemphigus vulgaris (PV).

"The approval of biosimilars such as RUXIENCE is an important development for the treatment of certain cancers and autoimmune conditions," said Igor Aurer, M.D., Ph.D., Professor of Medicine and Head of Hematology Division, University Hospital Centre Zagreb, Croatia. "It's a step toward allowing clinicians an additional treatment option which can help improve access for patients in need of this established medicine."

The EC approval is based on a comprehensive data package which demonstrated biosimilarity of RUXIENCE to the reference product. This includes results from the REFLECTIONS B3281006 clinical comparative study, which evaluated the efficacy, safety and immunogenicity, pharmacokinetics and pharmacodynamics of RUXIENCE and found no clinically meaningful differences in safety or efficacy compared to the reference product in patients with CD20-positive, low tumor burden follicular lymphoma.

"Biosimilars like RUXIENCE exhibit a similar safety and efficacy profile to the originator product and have the potential to improve treatment access while reducing healthcare costs," said Masum Hossain, regional president, Oncology International Developed Markets at Pfizer. "Building on our ongoing commitment to bring biosimilars to market, we look forward to making RUXIENCE available to patients in the EU in the coming months."

Biosimilars have been a significant catalyst for change for the healthcare industry over the last decade, with the potential to help create more sustainable healthcare systems. With more than 10 years of global in-market experience and a portfolio which now includes seven approved biosimilar products in Europe. This approval follows the positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) in January 2020. RUXIENCE was recently made available to adult patients in the United States for the treatment of NHL, CLL, GPA and MPA and also launched in Japan in January 2020.

Read also: Mylan, Pfizer Upjohn merger gets delayed in light on coronavirus