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Following European Medicines Agency (EMA) approval, the Medicines & Healthcare Products Regulatory Agency (MHRA) has authorised Truxima®, a biosimilar of rituximab, for use – making it the first biosimilar monoclonal antibody licensed for the treatment of cancer.1,2
Truxima® is licensed for the treatment of conditions including non-Hodgkin lymphoma, chronic lymphocytic leukaemia and rheumatoid arthritis.1,2
Rituximab currently costs the NHS around £167million per year.3 As Truxima® is intended to be less expensive than the reference product, it has the potential to make significant cost savings to the NHS.
Napp Pharmaceuticals today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has determined that Truxima® (rituximab) be granted Marketing Authorisation in the UK for all indications of the reference biologic, including non-Hodgkin lymphoma, chronic lymphocytic leukaemia and rheumatoid arthritis1,2 (see About Truxima®, below, for full list of license indications) – making it the first biosimilar monoclonal antibody for the treatment of cancer available in the UK.1
Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in the UK, affecting approximately 3,200 people each year.4 Non-Hodgkin lymphoma (NHL) is the fifth most common cancer among UK adults overall.5 Truxima® is also approved for use in rheumatoid arthritis – which affects approximately 700,000 UK adults6 – as well as the systemic vasculitides granulomatosis with polyangiitis (GPA) and microscopic polyangiitis.1,2
Professor Simon Rule, Professor of Haematology at Derriford Hospital, Plymouth, comments: “We have seen the major impact that biosimilar medicines can have on healthcare systems, and the availability of biosimilar rituximab will be no different. Now that the first biosimilar for the treatment of cancer is being introduced in the UK, a greater number of patients will have the opportunity to benefit from innovative oncology treatments, enabling us to help more and more people living with debilitating diseases like non-Hodgkin lymphoma.”
The approval of Truxima® was granted on the basis of rigorous clinical testing that demonstrated biosimilarity with biologic therapy intravenous Mabthera®.1 In 2015, the reference rituximab earned $7.1billion, making it the world’s top selling cancer drug.7 While it demonstrates the same efficacy, safety and immunogenicity profile, Truxima® is intended to be less expensive than the reference rituximab, and offers UK physicians the opportunity to provide the same quality healthcare to patients at a significantly lower cost.8
“The approval of Truxima® in the UK has the potential to create significant cost savings for the licensed indications, and represents an important opportunity for both patients and the NHS”, said Andrew Roberts, Market Access Director at Napp and Vice Chair of the British Biosimilar’s Association (BBA). “If all patients currently prescribed the reference product were switched to Truxima®, the yearly savings could have a major impact on our health service. We hope that the money saved through prescribing of Truxima® will be re-invested elsewhere in the system, such as in patient services or reimbursement for other innovative medicines. With early adoption and optimum use, the potential benefits are huge.”
Napp, an independent associate of the Mundipharma group, has exclusive rights to market and distribute Truxima® in the UK. Truxima® is the second biosimilar monoclonal antibody to be marketed and distributed by the organisation, which launched Remsima® in 2015. The launch of Truxima® cements Napp’s commitment to improving patient access to these new, advanced therapies, and confirms their place as leaders in marketing biosimilars.
Truxima® will only be available in European markets after necessary patent clearances.
About Napp Pharmaceuticals Limited
Napp Pharmaceuticals Limited is a privately owned UK organisation based in the heart of the Cambridge science community, and part of a worldwide network of independent associated companies across 48 countries. Napp has grown up with the NHS, providing innovative medicines to patients in the UK since the 1920s. Napp is committed to improving patient outcomes and ensuring the sustainability of healthcare. At Napp, we are proud of our heritage, which began in the treatment of chronic pain and has expanded into respiratory medicine, oncology and inflammatory disorders.
Truxima® is a genetically engineered chimeric murine/human monoclonal immunoglobulin G1 kappa antibody assessed by the EMA as a rituximab biosimilar. The therapeutic indications as well as the dosing regimen for Truxima® will be the same as those of the reference rituximab product.
Non-Hodgkin lymphoma (NHL)
Follicular lymphoma (FL)
· Previously untreated stage III – IV FL in combination with chemotherapy
· Maintenance therapy in patients responding to induction therapy
· Monotherapy in stage III – IV FL patients who are chemo-resistant or in their second or subsequent relapse after chemotherapy
Diffuse large B-cell lymphoma (DLBCL)
CD20+ DLBCL in combination with CHOP chemotherapy
Chronic lymphocytic leukaemia (CLL)
Previously untreated and relapsed/refractory CLL in combination with chemotherapy
Rheumatoid arthritis (RA)
In combination with methotrexate, for adult patients with severe active RA who have had an inadequate response or intolerance to other DMARDs including at least one anti-TNF therapy
Granulomatosis with polyangiitis and microscopic polyangiitis
In combination with glucocorticoids for the induction of remission in adults with severe active granulomatosis with polyangiitis and microscopic polyangiitis
Biosimilar is a term used to describe officially approved subsequent versions of biopharmaceutical medicines that are made available by a different company following patent and exclusivity expiry on the original product. Biosimilars are classed as biologic medical products, which mean they contain an active drug substance that is comprised of, or derived from, a living organism. Biosimilars are strictly regulated and need to demonstrate comparability to the previously approved reference product via a thorough development programme including quality, nonclinical and clinical data.
® TRUXIMA is a registered trade mark of Celltrion, Inc. and is used under licence.
® MABTHERA is a registered trade mark of F. Hoffmann-La Roche AG.
1. EMA. Human Medicines. Truxima [last accessed February 2017]
2. Napp Pharmaceuticals Limited. Truxima concentrate for solution for infusion summary of product characteristics [last accessed February 2017]
3. ABPI. Top products in the UK. Available at: http://www.abpi.org.uk/industry-info/archive/knowledge-hub/uk-economy/Pages/products.aspx [last accessed January 2017]
4- Macmillan Cancer Support. Understanding Chronic Lymphocytic Leukaemia. Available at: http://www.macmillan.org.uk/information-and-support/leukaemia/chronic-lymphocytic/understanding-cancer/about-cll.html [last accessed January 2017]
5. Macmillan Cancer Support. Understanding Non-Hodgkin Lymphoma. Available at: http://www.macmillan.org.uk/information-and-support/lymphoma/lymphoma-non-hodgkin/understanding-cancer [last accessed January 2017]
6. The British Society for Rheumatology. Simple Tasks – Rheumatology in the UK: The problem. The impact. The solutions. Available at: http://www.rheumatology.org.uk/patient_information/simple_tasks/did_you_know.aspx [last accessed January 2017]
7. Pharmaceutical Technology. The world’s most sold cancer drugs in 2015. Available at: http://www.pharmaceutical-technology.com/features/featurethe-worlds-most-sold-cancer-drugs-in-2015-4852126/ [last accessed January 2017]
8. Laslop A. Biosimilar monoclonal antibodies—challenges and opportunities in Europe. GaBI Journal. 2013; 2: 110–111