Is it time for biosimilars in autoimmune diseases?

Ebbers, 2012, Interchangeability, immunogenicity and biosimilars, Nat Biotechnol, 30, 1186, 10.1038/nbt.2438 Schellekens, 2004, How similar do ‘biosimilars’ need to be?, Nat Biotechnol, 22, 1357, 10.1038/nbt1104-1357 2012, Global Biosimilars Market — Products, Applications and Regulations, Wall St J Leardini, 2012, The impact of the profile of biologics on treatment costs, Autoimmun Rev Tan, 2012, Characterization and comparison of commercially available TNF receptor 2-Fc fusion protein products, MAbs, 4, 761, 10.4161/mabs.22276 Atzeni, 2012, Different effects of biological drugs in rheumatoid arthritis, Autoimmun Rev Epis, 2012, Tight control applied to the tight control applied to the biological therapy of rheumatoid arthritis, Autoimmun Rev Kay, 2011, Biosimilars: a regulatory perspective from America, Arthritis Res Ther, 13, 112, 10.1186/ar3310 Health Canada Health Products and Food Branch 2012, Approval of biosimilars in the USA—dead ringers?, Lancet, 379, 686-6 Liang, 2011, China's perspective on similar biotherapeutic products, Biologicals, 39, 312, 10.1016/j.biologicals.2011.06.020 2012, Samsung halts clinical tests for rituximab biosimilar Yoo, 2012, A randomized, double-blind, phase 3 study demonstrates clinical equivalence of ct-p13 to infliximab when co-administered with methotrexate in patients with active rheumatoid arthritis, Ann Rheum Dis, 71, 359, 10.1136/annrheumdis-2012-eular.2600 Park, 2012, A randomized, double-blind, phase 1 study demonstrates equivalence in pharmacokinetics, safety, and efficacy of ct-p13 and infliximab in patients with ankylosing spondylitis, Ann Rheum Dis, 71, 111, 10.1136/annrheumdis-2012-eular.1850 Gu, 2011, Comparative pharmacokinetics and tolerability of branded etanercept (25mg) and its biosimilar (25mg): a randomized, open-label, single-dose, two-sequence, crossover study in healthy Korean male volunteers, Clin Ther, 33, 2029, 10.1016/j.clinthera.2011.10.022 Yi, 2012, Comparative pharmacokinetics of HD203, a biosimilar of etanercept, with marketed etanercept (Enbrel®): a double-blind, single-dose, crossover study in healthy volunteers, BioDrugs, 26, 177, 10.2165/11631860-000000000-00000 Ramos-Casals, 2007, Autoimmune diseases induced by TNF-targeted therapies: analysis of 233 cases, Medicine, 86, 242, 10.1097/MD.0b013e3181441a68 Atzeni, 2012, Immunogenicity and autoimmunity during anti-TNF therapy, Autoimmun Rev Perez-Alvarez, 2013, Biologics-induced autoimmune diseases, Curr Opin Rheumatol, 25, 56, 10.1097/BOR.0b013e32835b1366 Roger, 2007, Biosimilars: opportunity or cause for concern?, J Pharm Pharm Sci, 10, 405 Gershon, 2002, Pure red-cell aplasia and recombinant erythropoietin, N Engl J Med, 346, 1584, 10.1056/NEJM200205163462015 Bennett, 2004, Pure red-cell aplasia and epoetin therapy, N Engl J Med, 351, 1403, 10.1056/NEJMoa040528 Ebbers, 2012, Effective pharmaceutical regulation needs alignment with doctors, Drug Discov Today, 17, 100, 10.1016/j.drudis.2011.09.018