Results of the PROPER study, an interim analysis assessing the safety and efficacy of switching from Abbvie’s Humira to Samsung Bioepsis’s biosimilar adalimumab product, SB5, were presented last week at the European Crohn’s and Colitis Organization’s annual meeting. SB5 received EU marketing authorization in August 2017. According to the presentation, the PROPER study was “designed to provide insights into outcomes of the transition” from Humira to SB5 “outside the controlled, randomised, clinical trial setting.” 462 patients with Crohn’s disease were included in the interim analysis, and the presentation concluded that the “transition from [Humira] to SB5 was generally safe and effective in patients with Crohn’s disease over 48 weeks of follow up.”
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