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Sandoz reports that biosimilar candidate to Enbrel meets efficacy endpoint as psoriasis treatment
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Sandoz, a division of Novartis, recently announced that the study comparing safety and efficacy of its biosimilar candidate to Enbrel met its primary endpoint at week 12.
The biosimilar candidate to Enbrel (etanercept, Amgen) and the originator product, etanercept, were compared for safety and efficacy in patients with moderate-to-severe plaque-type psoriasis, and data results were presented at Psoriasis 2016, the 5th Congress of the Psoriasis International Network, Paris, according to a press release from Novartis.
“The EGALITY study is a landmark in clinical trial design,” Diamant Thaçi, MD, of the Comprehensive Center for Inflammation Medicine, University Medical School Schleswig-Holstein, Lubeck, Germany, stated in the release. “Data have been collected from over 500 patients in 1 year with multiple treatment switches where a patient receives either the biosimilar etanercept candidate or the originator product on a number of alternate occasions. Data from this study, in addition to analytical, functional and preclinical studies, provide confidence in the comprehensive data package that is the basis for biosimilar medicine approval and use by health care practitioners.”
The study was a randomized double-blind trial of 531 patients at 74 dermatology clinics in 11 European countries and South Africa, according to the release. The primary endpoint of achieving equivalence in Psoriasis Area and Severity Index (PASI) 75 at week 12 was met.
Similarity between the biosimilar etanercept candidate and etanercept in terms of safety and immunogenicity, were confirmed through additional data, and there was comparable incidence of adverse events at week 12, according to the release.
The FDA Arthritis Advisory Committee voted 20-0 earlier this week in favor of recommending the approval of GP2015, Sandoz’s proposed biosimilar to Amgen’s Enbrel.
“The EGALITY data, showing our biosimilar etanercept to be bioequivalent to the originator product, is part of the comprehensive data package submitted to the [European Medicines Agency] and FDA,” Malte Peters, head global clinical development, Biopharmaceuticals, Sandoz, stated in the release.
Reference: www.novarits.com