Study Shows Sandoz Biosimilar Equivalent to Originator Drug

Sandoz, a Novartis division, today announced results from the EGALITY trial in which the primary endpoint of achieving equivalence in Psoriasis Area and Severity Index (PASI) 75 response rates at week 12 was met. The study compared the safety and efficacy of its biosimilar etanercept candidate with the originator product, Enbrel in patients with moderate-to-severe chronic plaque-type psoriasis and was presented at Psoriasis 2016, the 5th Congress of the Psoriasis International Network (PIN), Paris, France.

“The EGALITY data, showing our biosimilar etanercept to be bioequivalent to the originator product, is part of the comprehensive data package submitted to the EMA and FDA ... If our biosimilar etanercept is approved for the same indications as the originator product, more patients with chronic inflammatory conditions like rheumatoid arthritis and psoriasis will have access to life-changing biologic treatment options” – Malte Peters, Head Global Clinical Development, Biopharmaceuticals, Sandoz

Additional data from the study confirms similarity between the biosimilar etanercept candidate and the originator product in terms of safety and immunogenicity; the incidence of adverse events at week 12 was comparable.

“The EGALITY study is a landmark in clinical trial design. Data has been collected from over 500 patients in one 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 pre-clinical studies, provides confidence in the comprehensive data package that is the basis for biosimilar medicine approval and use by healthcare practitioners.” – Prof. Diamant Thaçi, Comprehensive Center for Inflammation Medicine, University Medical School Schleswig-Holstein, Lubeck.

Sandoz announced that its biosimilar etanercept candidate was accepted by the EMA and FDA for regulatory review in the second half of 2015. Sandoz is seeking approval for all indications included in the label of the originator product, which is used to treat various inflammatory conditions, including rheumatoid arthritis and psoriasis.

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. This will be enabled by 11 filings over a three-year period (2015-2017) having already submitted six and had one approved. 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.