New data demonstrate Sandoz proposed biosimilar adalimumab has equivalent efficacy to reference medicine

Sandoz proposed biosimilar adalimumab (GP2017) shown to have equivalent efficacy and a similar safety profile as reference medicine, Humira ^*. Comprehensive development program show potential of GP2017 to treat inflammatory diseases, such as rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis Study reinforces strength of Sandoz pipeline and its key role in the broader Novartis immunology portfolio Holzkirchen, 6 March 2017 - Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, today presented data for its proposed biosimilar adalimumab (GP2017). The Phase 3 confirmatory efficacy, safety and immunogenicity study met its primary endpoint demonstrating GP2017 has equivalent efficacy to the reference medicine, Humira . Results were presented at the American Academy of Dermatology (AAD) in Orlando, Florida. The primary endpoint of the study was the proportion of patients who achieved a 75% improvement at Week 16, as measured by the Psoriasis Area and Severity Index (PASI). Data from the study confirmed equivalent efficacy by demonstrating PASI 75 response rates of 67% for proposed biosimilar adalimumab and 65% for the reference medicine in patients with moderate to severe, chronic plaque psoriasis. "Currently, it is estimated that as few as five percent of eligible psoriasis patients get the biologics they need" said Mark Levick, MD PhD, Global Head of Development, Biopharmaceuticals, Sandoz.