Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, 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. “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. In the third period, the patients continued to receive their last treatment at week 30 up to week 52.
From baseline to week 52, the percentage change in Psoriasis Area and Severity Index (PASI) score was comparable between biosimilar etanercept and the originator product. EGALITY also confirms a comparable safety profile of the two medicines over 52 weeks, with similar incidence rates of treatment-emergent adverse events seen in all study arms. The primary endpoint of achieving equivalence in PASI 75 response rates were met at week 12. These data were presented at the congress of the Psoriasis International Network (PIN), 2016.
The FDA approved Sandoz biosimilar etanercept in August 2016 for all indications included in the label of the originator product, which is used to treat various inflammatory conditions including rheumatoid arthritis, plaque psoriasis and psoriatic arthritis. It is currently under regulatory review by the EMA after the submission was accepted in the second half of 2015.
Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global leader in biosimilars and currently markets three biosimilars. Sandoz has a leading biosimilar pipeline and plans to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020. As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.