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Norwegian study may be slowing adoption of biosimilar infliximab Posted 24/10/2014

Norway is funding clinical studies in which patients will be switched from originator biological drugs to biosimilars [1]. However, some have speculated that the NOR-SWITCH study is actually slowing the adoption of biosimilar infliximab in Norway.

The Norwegian study, NOR-SWITCH, was announced in January 2014 and will compare Johnson & Johnson’s and Merck’s rheumatoid arthritis blockbuster Remicade (infliximab) to Celltrion’s biosimilar Remsima (infliximab).

The NOR-SWITCH study is designed to generate safety and efficacy data to reassure physicians that the biosimilar version is just as good and that could facilitate greater switching of patients who are already receiving Remicade. However, data presented by Dr Steinar Madsen, Medical Director at the Norwegian Medicines Agency (NoMA), at the 2nd Annual Biosimilars & Biobetters Congress, held in London, UK, on 3–4 April 2014, shows a marked slowing of Remsima’s adoption.

By June 2014, Remsima had captured a 20% volume market share of the overall infliximab market, driven by a 39% discount versus Remicade. But between June and August 2014 the volume market share for Remsima remained at approximately 20%, which Madsen believes is due to the announcement of the impending NOR-SWITCH study, which is planned to start in the fourth quarter of 2014.

Norway’s Ministry of Health is carrying out the government funded study in 18 participating hospitals across the country. The phase IV study will enrol 500 patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis in order to assess the safety and efficacy of switching from Remicade to the biosimilar. The study is estimated to be completed by May 2016.

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Reference
1.   GaBI Online - Generics and Biosimilars Initiative. Norwegian study hopes to increase biosimilars uptake in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 24]. Available from: www.gabionline.net/Biosimilars/General/Norwegian-study-hopes-to-increase-biosimilars-uptake-in-Europe 

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Source: Clinicaltrials.gov, NoMA, NorCrin

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