BioDrugs (2018) 32:193–199 https://doi.org/10.1007/s40259-018-0283-4 SYSTEMATIC REVIEW Efﬁcacy and Safety Outcomes for Originator TNF Inhibitors and Biosimilars in Rheumatoid Arthritis and Psoriasis Trials: A Systematic Literature Review 1,2 3 4 5 • • • • Robert J. Moots Cinzia Curiale Danielle Petersel Catherine Rolland 4 6 Heather Jones Eduardo Mysler Published online: 22 May 2018 Springer International Publishing AG, part of Springer Nature 2018 Abstract patients with RA receiving originator biologics and biosimilars Objective Regulatory approval of biosimilar versions of orig- in biosimilar trials than among patients receiving the originator inator biotherapeutics requires that new biological products be biologics in pivotal trials. In etanercept studies in PsO, a dif- highly similar to originator products, with no clinically mean- ference was observed in Psoriasis Area and Severity Index 75% ingful differences in safety, purity, and potency. In some trials response rates between biosimilar and pivotal trials. Insufﬁcient of biosimilars of tumor necrosis factor inhibitors for the treat- efﬁcacy data were available from adalimumab and inﬂiximab ment of rheumatoid arthritis (RA) and plaque psoriasis (PsO), biosimilar studies in PsO to determine any differences in treat- pre-speciﬁed margins for efﬁcacy and safety have been met, but ment responses between pivotal and biosimilar studies.
BioDrugs – Springer Journals
Published: May 22, 2018
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