title: Biosimilars in Dermatology: Current Situation (Part II).
abstract: The first biosimilar version of a biologic agent used to treat psoriasis (infliximab) entered the Spanish market on February 16 of this year, and more biosimilars can be expected to follow in the coming months and years. Logically, this new situation will have economic repercussions and alter prescribing patterns among dermatologists. In this second part of the review, we will look at several somewhat contentious issues, such as the extrapolation of indications, interchangeability, and automatic substitution. We will also review the biosimilars with indications for psoriasis currently in the clinical development pipeline and assess their potential to offer comparable efficacy and safety to the reference product while contributing to the sustainability of the public health care system.
authors.affiliation: Servicio de Dermatología, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, España. Electronic address: lpuig@santpau.cat.
authors.forename: L
authors.initials: L
authors.lastname: Puig
authors.affiliation: Servicio de Dermatología, Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria, España.
authors.forename: G
authors.initials: G
authors.lastname: Carretero
authors.affiliation: Servicio de Dermatología, Hospital Universitario de La Princesa, Madrid, España.
authors.forename: E
authors.initials: E
authors.lastname: Daudén
authors.affiliation: Servicio de Dermatología, Hospital Universitario Germans Trias i Pujol (HUGiT), Badalona, Barcelona, España.
authors.forename: C
authors.initials: C
authors.lastname: Ferrándiz
authors.affiliation: Unidad Clínica de Dermatología, Hospital de Alcañiz, Instituto Aragonés de Ciencias de la Salud (IACS), Alcañiz, España.
authors.forename: S E
authors.initials: SE
authors.lastname: Marrón
authors.affiliation: Servicio de Dermatología, Hospital de Manises, Valencia, España.
authors.forename: A
authors.initials: A
authors.lastname: Martorell
authors.affiliation: Servicio de Dermatología, Hospital Morales Meseguer, Murcia, España.
authors.forename: B
authors.initials: B
authors.lastname: Pérez-Suárez
authors.affiliation: Servicio de Dermatología, Complejo Hospitalario de Vigo, EOXI, Vigo , España.
authors.forename: C
authors.initials: C
authors.lastname: Rodriguez-Cerdeira
authors.affiliation: UGC Dermatología, Hospital Universitario Virgen de las Nieves, Granada, España.
authors.forename: R
authors.initials: R
authors.lastname: Ruiz-Villaverde
authors.affiliation: Servicio de Dermatología, Hospital General Universitario de Valencia, Valencia, España.
authors.forename: J L
authors.initials: JL
authors.lastname: Sánchez-Carazo
authors.affiliation: Servicio de Dermatología, Hospital Arnau de Vilanova, Valencia, España.
authors.forename: M
authors.initials: M
authors.lastname: Velasco
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000191:economics / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000191:economics / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D057915:Drug Substitution; D005062:European Union; D006801:Humans; D000069285:Infliximab / Q000009:adverse effects / Q000627:therapeutic use; D060735:Pharmacovigilance; D011565:Psoriasis / Q000188:drug therapy*; D013030:Spain; D013167:Spondylitis, Ankylosing / Q000188:drug therapy; D013810:Therapeutic Equivalency
chemical_list: D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D000069285:Infliximab
keywords: Adalimumab; Biologic; Biológico; Biosimilar; Clinical trials; Ensayos clínicos; Etanercept; Infliximab; Intercambiabilidad; Interchangeability; Legislación; Legislation; Psoriasis; Substitution; Sustitución