Europe approved its first biosimilar monoclonal antibody Inflectra/Remsima (infliximab) on 10 September 2013 [1]. The biosimilar is now recommended by the Norwegian Drug Procurement Cooperation (LIS) as the first choice, which carries out the procurement for all medicines financed by public hospitals in Norway. Gastroenterologists, however, are cautious about using the biosimilar ‘until more studies of the new medicine have been completed’ [2].
Until now, the biological options for patients with ulcerative colitis and Crohn’s disease in Norway have been infliximab infusion (Merck’s Remicade) or subcutaneous injection of adalimumab (AbbVie’s Humira), as well as golimumab (Merck’s Simponi) for patients with ulcerative colitis. All three medicines had a similar price in Norway and therefore, although LIS recommended using the lowest-cost option, the choice was largely based on individual preferences and route of administration. But with the introduction of biosimilar infliximab at 39% below the 2013 price level for Remicade, the Norweigian healthcare system expects to save approximately NOK 50,000 per patient for the first year of treatment, by recommending that the cheapest option be used. One small downside is that Inflectra/Remsima is administered as an infusion, compared to adalimumab or golimumab, which are administered subcutaneously. A fact that may lead to increased use of resources at outpatient clinics.
The LIS recommendation means that all new patients must be started on the biosimilar infliximab. However, gastroenterologists advise against switching patients already receiving treatment with Remicade to the less costly biosimilar, due to the lack of data. The Norwegian Government has, however, allocated NOK 20 million for a clinical study in the fields of rheumatology, gastroenterology and dermatology, during which a treatment-switching study is planned. This should hopefully go some way to assuring physicians of the efficacy and safety of biosimilars.
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References
1. GaBI Online – Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 9]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar
2. Moum B, Lundin KE. Biosimilar medicines in inflammatory bowel disease. Tidsskr Nor Laegeforen 2014;134(8):819-820. eCollection 2014.
Source: www.gabionline.net
