Truxima Receives Approval in EU for Autoimmune, Oncology Indications

Celltrion’s Truxima, a biosimilar of rituximab, has been granted approval from the European Medicines Agency (EMA) for its use in several cancers and autoimmune disorders. The drug has already been approved in Korea, and Celltrion plans to submit an application to the FDA this year.

According to a press release announcing the approval, Truxima is the first biosimilar monoclonal antibody approved as an oncology therapy. It has been indicated for the treatment of non-Hodgkin’s lymphoma and chronic lymphocytic leukemia, as well as autoimmune disorders (rheumatoid arthritis and granulomatosis with polyangiitis and microscopic polyangiitis).

In December 2016, the EMA issued a positive opinion that gave the application the green light for the subsequent marketing authorization. It did so after reviewing data on safety, efficacy, immunogenicity, pharmacodynamics, and pharmacokinetics that demonstrated convincing similarity between Truxima and the reference rituximab, sold by Roche as MabThera. The Celltrion press release declared that these “trials were conducted in over 600 patients and include data up to 104 weeks.”

Truxima is manufactured in Korea, where Celltrion is based. In November, when Korea’s Ministry of Food and Drug Safety approved Truxima, representatives voiced confidence about the drug’s chances of success with the EMA, as its application was then underway, and eventually with the FDA. The company has not yet announced an FDA application, which it said would be submitted sometime in early 2017.

Mundipharma has distribution rights in 7 European countries, and plans to have Truxima on the market starting in the second quarter of 2017. Teva and Celltrion have already formed a $160 million partnership that will allow Teva to sell Truxima in the United States upon its approval by the FDA, according to a BioPharma Reporter article on the EMA approval.

Celltrion’s manufacturing facilities are undergoing expansion in hopes of boosting production capacity to 310,000 liters by 2021, reflecting its enthusiasm about the potential for biosimilars to disrupt the market and expand access due to their lower price. The press release quoted projections from László Gulácsi, a Hungarian professor and consultant, who said that savings could reach €570 million across the 28 EU countries over a 3-year period, allowing 49,000 new patients to receive the treatment.

"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,” said Celltrion chairman Jung-Jin Seo at a meeting in Paris, according to the press release.