Celltrion launches world’s first biosimilar monoclonal antibody in 12 new European markets

remsima Celltrion

Celltrion Healthcare has today announced the launch of Remsima (infliximab) in 12 European markets: Austria, Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain, Sweden and the UK. The treatment to the treatment of autoimmune diseases is now available in 31 countries.

Remsima, developed by the South Korean company Celltrion, is the world’s first biosimilar monoclonal antibody (mAb) to be approved by the European Medicines Agency (EMA). It is indicated for the treatment of adult and pediatric Crohn’s disease (CD), adult and pediatric ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, and psoriatic arthritis. Furthermore, Remsima is an anti-tumor necrosis factor (anti-TNF) mAb that is used for reducing inflammation and improving other symptoms of the diseases for which it is indicated.

While biologics have positively impacted patient treatment, the high cost of using such drugs places a considerable burden on healthcare systems and can affect patient access to treatment. Biosimilars have the potential to offer cost savings for health services, particularly as they are often used to treat long-term conditions. The use of biosimilars may help to increase patient access to treatment and allow patients to be treated earlier in their disease pathway.

Dr Antonio López-SanRomán, a specialist in gastroenterology at the University Hospital Ramón y Cajal (Spain) said: “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.

Clinical trials have demonstrated comparability of Remsima in quality, safety and efficacy to its reference medicinal product Remicade. Remsima received marketing authorization from the EMA on 10 September 2013 and is currently under review by the United States Food and Drug Administration (FDA).

Dr Stanley Hong, President of Celltrion Healthcare, 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.

After all, it seems that Europe is adopting biosimilars faster than the US, although the FDA is getting closer to its first authorization, with Oncologic Drugs Advisory Committee’s recommendation to approve Sandoz’s biosimilar filgrastim.

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