Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, has 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 – reported on www.news-medical.net – 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,’ said Malte Peters, Head Global Clinical Development, Biopharmaceuticals, Sandoz.
‘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.’
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
