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Truxima™, the first biosimilar mAb in oncology, granted EU marketing authorisation

Celltrion Healthcare today announced that the European Commission has approved Truxima™ (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 microscopic polyangiitis.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”.

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Notes to editors:

About hematological cancers

Hematological cancers begin in blood-forming tissue or cells of the immune system. There are three common types of hematological cancers: lymphoma, leukaemia and myeloma. There are many types of NHL, the most common group is B cell lymphomas, of which follicular lymphoma and diffuse large B cell lymphoma are the most common. CLL is a type of leukaemia and is characterised by accumulation of monoclonal B cells (a type of white blood cell).

About rheumatoid arthritis

In Europe more than 2.9 million people have RA, many of whom are of working age. On average, every third person with RA becomes work disabled and up to 40 per cent leave work completely within 5 years of diagnosis.4 Although there is no cure for RA, there are many treatments that can reduce inflammation and ease pain. As with all rheumatic diseases early diagnosis and intervention is key.

About Truxima™ (biosimilar rituximab)

Truxima™ is a mAb that targets CD20, a protein found on the surface of most B cells. Overactive B cells can stimulate attack of healthy cells in immune-related diseases such as RA. B cells are also implicated in some types of hematological cancer including NHL and CLL. B cells express CD20 at many stages of their development making the protein a good target for treatments.

Truxima™ is approved in the EU for the treatment of people with NHL, CLL, RA, granulomatosis with polyangiitis and microscopic polyangiitis. Further details of the approved indications and safety information for Truxima™ are available in the summary of product characteristics (SmPC).1

Overview of Truxima™ studies

Phase 1 clinical data demonstrated the PK of Truxima™ and reference rituximab were statistically equivalent over 24 weeks after a single course of treatment, and that their efficacy, PD, immunogenicity and safety were similar up to 2 courses of treatments (up to 72 weeks).2

A phase 1 open label extension study showed that switching to Truxima™ from reference rituximab was similarly effective with comparable safety to continuing Truxima™ for two years.2

Three phase 3 studies in patients with RA, advanced follicular lymphoma and low-tumor-burden follicular lymphoma (LTBFL) are ongoing:

  • Truxima™ showed highly similar efficacy, PK, PD, immunogenicity and safety profiles to reference rituximab in people with RA up to 48 weeks2
  • Truxima™ showed equivalent PK to reference rituximab with similar efficacy, PD, immunogenicity and safety profiles up to 8 cycles of treatment (every 3 weeks) in people with advanced follicular lymphoma2

About Celltrion Healthcare

Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines. For more information please visit:


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].

4 NRAS, European Fit for Work Report. Available at . [Last accessed February 2017].


Celltrion Healthcare
Emma Gorton
+44 203 817 6591
Anna Reilly
+44 203 817 6586



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