The European Commission approved Truxima as a biosimilar of rituximab (sold under the brand name Rituxan in the U.S.) in the EU for all indications approved for rituximab, including rheumatoid arthritis (RA) and certain cancers, such as non-Hodgkin’s lymphoma.
With this approval, Truxima became the first biosimilar monoclonal antibody (mAb) approved for a cancer indication worldwide.
Celltrion Healthcare developed Truxima as a mAb that targets CD20, a protein found on the surface of the majority of immune B-cells. Overactive B-cells can stimulate the attack of healthy cells in immune-related diseases like RA.
“We are excited to offer the first biosimilar mAb in oncology. With our partners across Europe, we will work together to ensure that Truxima is available to the many patients who can benefit from this treatment,” Jung-Jin Seo, chairman of the Celltrion Group, said at a meeting in Paris, according to a press release.
“For healthcare systems burdened with high-cost oncology treatments, we are pleased to provide an option that has the potential to offer significant savings whilst ensuring patients retain access to high-quality and effective treatments,” Seo added.
Truxima is approved in the European Union for the treatment of RA and certain hematological cancers. The approval is based on evidence submitted to the European Medicines Agency (EMA) showing similar profiles of effectiveness, safety, immunogenicity, drug effects, and drug properties between Truxima and rituximab in patients with RA and advanced follicular lymphoma (a type of non-Hodgkin’s lymphoma).
The clinical trials supporting this approval enrolled 600 patients and included data from 104 weeks.
“Biosimilar rituximab has been shown to have comparable efficacy and safety to reference rituximab in a large program of trials providing convincing evidence for the similarity of the two products. This has been recognized by the regulatory authorities, and hopefully this will pave the way for further innovation in this area,” said Bertrand Coiffier, global principle investigator of the advanced follicular lymphoma study, head of the Department of Hematology at Hospices Civils de Lyon and a professor at the University Claude Bernard in Lyon, France.
Biosimilars can cut costs significantly, both for healthcare systems and for patients. If healthcare systems adopt the use of biosimilars, more patients can afford to receive treatment.
“Assuming the price of biosimilar rituximab is 70 percent compared to reference rituximab, and the market share of biosimilar rituximab is 30 percent (first year), 40 percent (second year) and 50 percent (third year), over this three-year time period the budget savings across the 28 countries of the EU would be around €570 million,” said László Gulácsi, a professor at Corvinus University of Budapest.
“This equates to 49,000 new RA, [non-Hodgkin’s lymphoma] and CLL [chronic lymphocytic leukemia] patients who could be receiving life-changing treatment, which is clearly a huge aggregate health-gain at both a national and EU level,” he concluded.