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First biosimilar mAb in oncology is granted EU marketing authorisation

Celltrion Healthcare has announced that the European Commission has approved TruximaTM (biosimilar rituximab) for all indications of reference rituximab in the European Union (EU).

Truxima™ is the first biosimilar monoclonal antibody (mAb) approved in an oncology indication worldwide. The approval of Truxima™ builds on Celltrion Healthcare’s strong global clinical biosimilar programme.

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”, said Jung-Jin Seo, Chairman of Celltrion Group, speaking at a meeting of their European partners in Paris. “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”.

Truxima™ is approved in the EU for the treatment of people with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopicpolyangiitis.1 This approval is based on the totality of evidence submitted to the European Medicines Agency showing compelling similarity between Truxima™ and reference rituximab in terms of efficacy, safety, immunogenicity, pharmacodynamics (PD) and pharmacokinetics (PK) in patients with RA and advanced follicular lymphoma, a type of NHL.2 These trials were conducted in over 600 patients and include data up to 104 weeks.1

Dr Bertrand Coiffier, the global principle investigator of the advanced follicular lymphoma study, Head of the Department of Hematology at Hospices Civils de Lyon and Professor at the University Claude Bernard, Lyon, France said, “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 recognised by the regulatory authorities, and hopefully this will pave the way for further innovation in this area”.

Budget saving impact

Biosimilars have the potential to offer cost savings for healthcare systems and therefore the potential to increase patient access to biological therapies.2,3

Assuming the price of biosimilar rituximab is 70% compared to reference rituximab, and the market share of biosimilar rituximab is 30% (first year), 40% (second year) and 50% (third year), over this three-year time period the budget savings across the 28 countries of the EU would be around €570 million”, said Prof László Gulácsi, Head of Department of Health Economics, Corvinus University of Budapest; HTA Consulting Budapest, Hungary. “This equates to 49,000 new RA, NHL and CLL patients who could be receiving life-changing treatment which is clearly a huge aggregate health-gain at both a national and EU level”.


  1. Celltrion Healthcare data on file.
  2. European Commission. What you need to know about biosimilar medicinal products. Available at[Last accessed February 2017].
  3. World Health Organisation. Access to biotherapeutic products including similar biotherapeutic products and ensuring their quality, safety and efficacy. 2014. WHA67.21. Available at: [Last accessed February 2017].