European Medicines Agency Authorizes Marketing of Pfizer's Ruxience

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) Friday recommended marketing authorization for Pfizer's Ruxience, its rituximab biosimilar.

The opinion of the CHMP will be reviewed by the European Commission, and a regulatory decision could be announced in the next 6 months. If approved, Ruxience will be Pfizer’s fifth regulated oncology biosimilar in Europe. Ruxience was approved by the FDA in July of 2019 and launched January last in the United States.

The originator rituximab is sold as Rituxan in the United States and and as MabThera in Europe and other regulatory territories.

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 non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris, according to a press release.

The chief development officer of oncology at Pfizer Global Product and Development, Chris Boshoff, MD, PhD, said of the authorization, “Biosimilars like Ruxience can play an important role in cancer care, helping to expand patient access to potentially life-changing therapies. We are committed to bringing biosimilars like Ruxience to the market as a treatment option with similar safety and efficacy to the originator product at a potentially lower cost.”

The regulatory submission is supplemented by results form a clinical comparative study, which “found no clinically meaningful differences in safety or efficacy compared to the reference product in patients with CD20-positive, low tumor burden follicular lymphoma,” according to the company.

Pfizer recently announced it expects its 3 oncology biosimilar products to have the lowest wholesale acquisition cost (WAC) among currently available bevacizumab, rituximab, or trastuzumab biosimilars in the United States. Ruxience has a WAC of $71.68 per 10 mg, which is a 24% discount to the WAC of rituxan.