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Phase III Randomized Study of SB5, an Adalimumab Biosimilar, Versus Reference Adalimumab in Patients With Moderate-to-Severe Rheumatoid Arthritis.
Weinblatt ME, Baranauskaite A, Niebrzydowski J, Dokoupilova E, Zielinska A, Jaworski J, Racewicz A, Pileckyte M, Jedrychowicz-Rosiak K, Cheong SY, Ghil J. Weinblatt ME, et al. Among authors: niebrzydowski j. Arthritis Rheumatol. 2018 Jan;70(1):40-48. doi: 10.1002/art.40336. Epub 2017 Nov 21. Arthritis Rheumatol. 2018. PMID: 28950421 Free PMC article. Clinical Trial.
A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy.
Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, Baranauskaite A, Yatsyshyn R, Mekic M, Porawska W, Ciferska H, Jedrychowicz-Rosiak K, Zielinska A, Choi J, Rho YH, Smolen JS. Choe JY, et al. Among authors: niebrzydowski j. Ann Rheum Dis. 2017 Jan;76(1):58-64. doi: 10.1136/annrheumdis-2015-207764. Epub 2015 Aug 28. Ann Rheum Dis. 2017. PMID: 26318384 Free PMC article. Clinical Trial.
Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results.
Smolen JS, Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, Baranauskaite A, Yatsyshyn R, Mekic M, Porawska W, Ciferska H, Jedrychowicz-Rosiak K, Zielinska A, Choi J, Rho YH. Smolen JS, et al. Among authors: niebrzydowski j. Rheumatology (Oxford). 2017 Oct 1;56(10):1771-1779. doi: 10.1093/rheumatology/kex254. Rheumatology (Oxford). 2017. PMID: 28957563 Free PMC article. Clinical Trial.
Safety, immunogenicity and efficacy after switching from reference infliximab to biosimilar SB2 compared with continuing reference infliximab and SB2 in patients with rheumatoid arthritis: results of a randomised, double-blind, phase III transition study.
Smolen JS, Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, Baranauskaite A, Yatsyshyn R, Mekic M, Porawska W, Ciferska H, Jedrychowicz-Rosiak K, Zielinska A, Lee Y, Rho YH. Smolen JS, et al. Among authors: niebrzydowski j. Ann Rheum Dis. 2018 Feb;77(2):234-240. doi: 10.1136/annrheumdis-2017-211741. Epub 2017 Oct 17. Ann Rheum Dis. 2018. PMID: 29042358 Free PMC article. Clinical Trial.