Innovative study with three treatment switches confirms Sandoz biosimilar etanercept has equivalent efficacy to originator

No clinically meaningful differences between biosimilar etanercept and the originator product in safety and efficacy over 52 weeks. Innovative study design demonstrates switching between biosimilar etanercept and the originator product has no impact on safety and efficacy -   Sandoz biosimilar etanercept was approved by the FDA* in August 2016 and is currently under review by the EMA ** Holzkirchen, November 18, 2016 - Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, today announced the publication of the EGALITY study in the British Journal of Dermatology . The confirmatory clinical safety and efficacy study shows Sandoz biosimilar etanercept is equivalent to the originator product, Enbrel ***, in more than 500 adult patients over 52 weeks. The innovative design of the EGALITY study includes switched and continuous treatment arms. Patients who switched treatments crossed over between biosimilar etanercept and the originator product three times with no clinically meaningful differences in safety and efficacy. "Sandoz recognizes that clinicians need robust data on switching to confidently prescribe biosimilars. In EGALITY the same patients received treatment with biosimilar etanercept and the originator product in an alternating fashion and these three treatment switches had no impact on safety and efficacy," said Malte Peters M.D. Head Global Clinical Development, Biopharmaceuticals, Sandoz.