Phase III results for SB5 (adalimumab biosimilar) demonstrate equivalence to Humira in rheumatoid arthritis- Samsung Bioepis

Samsung Bioepis announced that SB5 (adalimumab biosimilar) demonstrated both equivalent efficacy and comparable safety in a 24-week Phase III clinical study versus Humira (adalimumab) in patients with mModerate to severe rheumatoid arthritis. The 24-week Phase III study of SB5, which randomized 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy, showed ACR20 response rate of 72.5% in the SB5 arm versus 72.0% in the Humira arm. The safety profile of SB5 was comparable to Humira. The latest results for SB5 will be presented at the upcoming 2015 Annual Meeting of the American College of Rheumatology and the Association for Rheumatology Health Professionals.

The field of competitors for adalimumab is crowded: SB5 from Samsung Bioepis/Merck is in Phase III, along with ABP 501 from AET Biotech/Amgen, and BI 695501 from Boehringer Ingelheim. There is also Exemptia from Zydus Cadila approved in India, BOW 050 from Epirius Biopharma and others in Phase III, CHS 1420 from Coherus Bioscience in Phase III, GP 2017 from Sandoz in Phase III, PF 01410293 from Pfizer in Phase III, and FKB 327 from FujiFilm Kyowa Kirin and ONS 3010 from OcoBiologics in early study.