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

Novartis International AG / Innovative study with three treatment switches confirms Sandoz biosimilar etanercept has equivalent efficacy to originator . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• No clinically meaningful differences between biosimilar etanercept and the originator product in safety and efficacy over 52 weeks[1]
   

Innovative study design demonstrates switching between biosimilar etanercept and the originator product has no impact on safety and efficacy[1]
 

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[1]. 

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. "This innovative study demonstrates that Sandoz is at the frontier of building trust and confidence in biosimilars to increase access to biologics for patients worldwide." Peters continued.

The 52-week EGALITY study was a randomized, double-blind trial which involved 531 adult patients with moderate to severe plaque psoriasis. The study was carried out over 12 months in 74 dermatology clinical sites across Europe and South Africa and consisted of three treatment periods. In the first 12-week period, patients received biosimilar etanercept or the originator product. In the second period, patients with at least 50% improvement of psoriasis symptoms were re-randomized into four groups; the first two groups continued with their original treatment and other two switched to the alternate treatment every six weeks until week 30[1]. In the third period, the patients continued to receive their last treatment at week 30 up to week 52.