World’s First Biosimilar Monoclonal Antibody Launched in 12 European Nations - European Medical Journal

World’s First Biosimilar Monoclonal Antibody Launched in 12 European Nations

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PHYSICIANS across Europe will be provided with a cost-effective new treatment option for the management of adult and paediatric Crohn’s disease (CD), adult and paediatric ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, and psoriatic arthritis, after the approval of the first biosimilar monoclonal antibody (mAb), RemsimaTM, by the European Medicines Agency (EMA).

Remsima (infliximab) has now been officially launched in 12 European nations: Austria, Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain, Sweden, and the UK, and is predicted to provide significant cost savings for health services. Clinical trials of Remsima, developed by Celltrion, Inc., have demonstrated its comparability to Remicade® in terms of safety, efficacy, and quality. Dr Stanley Hong, President of Celltrion Healthcare, Incheon, South Korea, said: “Autoimmune diseases can have a devastating impact on people’s lives so we are proud that Remsima is available for patients across the European Union, offering them a more accessible treatment option to manage their disease.”

While biologics have positively impacted the management of patients, their relatively high cost places a considerable burden on healthcare budgets and can also influence patient access to treatment. As national healthcare budgets come under increasing pressure, the use of biosimilars is predicted to offer significant cost savings, especially in the long-term treatment of chronic inflammatory diseases. Overall, biosimilars are projected to save European healthcare systems between €11.8 and €33.4 billion between 2007 and 2020, with the biggest savings predicted in France, Germany, and the UK; biosimilar mAbs are expected to deliver the greatest savings (€1.8-€20.4 billion). Data from a budget impact analysis presented at the European Crohn’s and Colitis Organisation’s (ECCO) 10th annual congress in Barcelona, Spain, predict that total 5-year healthcare savings ranging from €76 million to €336 million would be achievable through the use of Remsima in patients with CD in France, Italy, and the UK.

“It is encouraging to know that patients across the whole of Europe with diseases like Crohn’s and ulcerative colitis now have an additional treatment option in Remsima. It has already been used successfully around the world, and the availability of biosimilars such as Remsima could lead to cost savings to the healthcare system,” said Dr Antonio López-SanRomán, Inflammatory Bowel Disease Unit, University Hospital Ramón y Cajal, Madrid, Spain.

Zoë Webster


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