title: Biosimilars for psoriasis: clinical studies to determine similarity.
abstract: Biosimilars are drugs that are similar, but not identical, to originator biologics. Preclinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to determining biosimilarity. In this review, written by members of the International Psoriasis Council, we discuss how biosimilars are evaluated in a clinical setting, with emphasis on extrapolation of indication, interchangeability and optimal clinical trial design.
authors.affiliation: Oregon Medical Research Center, Portland, OR, U.S.A.
authors.forename: A
authors.initials: A
authors.lastname: Blauvelt
authors.affiliation: Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: L
authors.initials: L
authors.lastname: Puig
authors.affiliation: University of Rome Tor Vergate, Rome, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Chimenti
authors.affiliation: Dermatrials Research Inc., Hamilton, ON, Canada.|Venderm Innovations in Psoriasis, Hamilton, ON, Canada.
authors.forename: R
authors.initials: R
authors.lastname: Vender
authors.affiliation: Apollo Hospitals, Chennai, India.
authors.forename: M
authors.initials: M
authors.lastname: Rajagopalan
authors.affiliation: Department of Dermatology, University of São Paulo, São Paulo, Brazil.
authors.forename: R
authors.initials: R
authors.lastname: Romiti
authors.affiliation: Herllev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.
authors.forename: L
authors.initials: L
authors.lastname: Skov
authors.affiliation: Herllev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.
authors.forename: C
authors.initials: C
authors.lastname: Zachariae
authors.affiliation: Manchester Academic Health Science Centre, Department of Dermatology, University of Manchester, Salford Royal Hospital, Manchester, U.K.
authors.forename: H
authors.initials: H
authors.lastname: Young
authors.affiliation: Department of Dermatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: E
authors.initials: E
authors.lastname: Prens
authors.affiliation: Siaal Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.|Department of Quality Measurements and Research, Chief Physician's Office, Clalit Health Services, Tel Aviv, Israel.
authors.forename: A
authors.initials: A
authors.lastname: Cohen
authors.affiliation: International Psoriasis Council, St Louis, MO, U.S.A.
authors.forename: J
authors.initials: J
authors.lastname: van der Walt
authors.affiliation: Department of Dermatology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA, U.S.A.
authors.forename: J J
authors.initials: JJ
authors.lastname: Wu
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D017277:Drug Approval; D006801:Humans; D017410:Practice Guidelines as Topic; D011565:Psoriasis / Q000188:drug therapy*
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D059451:Biosimilar Pharmaceuticals