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Remsima has demonstrated comparability to the reference product, Remicade, in terms of safety, efficacy, and quality.
Mundipharma has launched the biosimilar version of infliximab (Remsima) in Germany, Italy, United Kingdom, Netherlands, Belgium, and Luxembourg. Remsima is the first biosimilar monoclonal antibody to be approved by the European Medicines Agency. The agency has determined that the biosimilar is comparable to the reference product, Remicade, in its safety, efficacy, and quality profiles across the approved indications. Two clinical trials confirm EMA’s preclinical evaluation of Remsima. The biosimilar is approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.
Remsima is expected to cost less than the reference product Remicade, delivering significant cost savings across Europe. The launch follows the expiry of the relevant patents and supplementary protection certificates.
“Mundipharma is constantly looking for solutions that meet the needs of payers as well as improving the lives of patients and the healthcare professionals who care for them,” commented Antony Mattessich, managing director, Mundipharma, in a press release.
It is believed that biosimilars can offer savings to European healthcare systems of between €11.8 billion and €33.4 billion between 2007 and 2020. The biggest savings are predicted in France, Germany, and the UK. Biosimilar monoclonal antibodies are expected to deliver the greatest savings, ranging from €1.8 to €20.4 billion in the same timeframe. The cost savings will enable European healthcare systems to treat more patients with the therapy, earlier in the disease pathway, and to reallocate resources.