Pfizer Gains European Commission Approval for Rituximab Biosimilar

Roughly 8 months after Ruxience (rituximab) was approved by the FDA, Pfizer has announced that the biosimilar has been approved by the European Commission (EC) for the same indications. A European market launch is anticipated in “coming months,” the company said.

Ruxience launched on the US market in January 2020.

The biosimilar is a monoclonal antibody (mAb) accepted by the EC 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).

In the United States last year, Ruxience was approved for all of the above indications except RA and PV.

The EC approval is based on a data package that demonstrated biosimilarity of RUXIENCE to the reference product, MabThera. The originator rituximab is sold as Rituxan in the United States.

This included 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 with the reference product in patients with CD20-positive, low-tumor-burden follicular lymphoma, Pfizer said.

“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,” he said.

RUXIENCE targets a protein called CD20, which is present on the surface of B lymphocytes, also known as B cells. When it attaches to CD20, rituximab helps destroy these B cells.

At about the same time that it launched Ruxience on the US market, Pfizer also introduced 2 other products: Trazimera, a trastuzumab biosimilar; and Zirabev, a biosimilar to bevacizumab.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) Friday recommended marketing authorization in January 2020.

According to the CHMP, Ruxience will be available as 100- and 500-mg concentrates for solution for infusion. Rituximab is used in conditions such as NHL, CLL, RA, GPA, MPA, and PV, according to a press release.