Abstract
A biosimilar is a biological medicinal product that is highly similar to an already authorized original biological medicinal product. The introduction of biosimilars may allow for a reduction in health care costs, due to discount pricing. Current clinical studies and real-world data suggest that the biosimilar SB4 is equivalent to etanercept with respect to efficacy and safety. Additional real-world safety data for SB4 via pharmacovigilance studies are needed to draw conclusions regarding the risks of rare adverse events such as serious infections and malignancy. Clinical trial design of biosimilars should be standardised to improve consistency, increase confidence and facilitate interpretation of data. Where there are health economic advantages of switching from originator to biosimilar, patients should be appropriately informed, and, ideally, in order to minimise nocebo responses and maximise benefit, switching should be undertaken by shared decision-making between the physician and patient on a case-by-case basis.