Biosimilars in Dermatology: Current Situation (Part II)
Actas Dermosifiliogr. 2015 Sep;106(7):550-4.
doi: 10.1016/j.ad.2015.04.008.
Epub 2015 Jun 3.
[Article in
English,
Spanish]
Authors
L Puig
1
, G Carretero
2
, E Daudén
3
, C Ferrándiz
4
, S E Marrón
5
, A Martorell
6
, B Pérez-Suárez
7
, C Rodriguez-Cerdeira
8
, R Ruiz-Villaverde
9
, J L Sánchez-Carazo
10
, M Velasco
11
; en nombre del Grupo de Psoriasis de Academia Española de Dermatología y Venereología
Affiliations
- 1 Servicio de Dermatología, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, España. Electronic address: lpuig@santpau.cat.
- 2 Servicio de Dermatología, Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria, España.
- 3 Servicio de Dermatología, Hospital Universitario de La Princesa, Madrid, España.
- 4 Servicio de Dermatología, Hospital Universitario Germans Trias i Pujol (HUGiT), Badalona, Barcelona, España.
- 5 Unidad Clínica de Dermatología, Hospital de Alcañiz, Instituto Aragonés de Ciencias de la Salud (IACS), Alcañiz, España.
- 6 Servicio de Dermatología, Hospital de Manises, Valencia, España.
- 7 Servicio de Dermatología, Hospital Morales Meseguer, Murcia, España.
- 8 Servicio de Dermatología, Complejo Hospitalario de Vigo, EOXI, Vigo , España.
- 9 UGC Dermatología, Hospital Universitario Virgen de las Nieves, Granada, España.
- 10 Servicio de Dermatología, Hospital General Universitario de Valencia, Valencia, España.
- 11 Servicio de Dermatología, Hospital Arnau de Vilanova, Valencia, España.
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.
Keywords:
Adalimumab; Biologic; Biológico; Biosimilar; Clinical trials; Ensayos clínicos; Etanercept; Infliximab; Intercambiabilidad; Interchangeability; Legislación; Legislation; Psoriasis; Substitution; Sustitución.
Copyright © 2015 Elsevier España, S.L.U. and AEDV. All rights reserved.
MeSH terms
-
Antibodies, Monoclonal / adverse effects
-
Antibodies, Monoclonal / economics
-
Antibodies, Monoclonal / pharmacokinetics
-
Antibodies, Monoclonal / therapeutic use*
-
Arthritis, Rheumatoid / drug therapy
-
Biosimilar Pharmaceuticals / adverse effects
-
Biosimilar Pharmaceuticals / economics
-
Biosimilar Pharmaceuticals / pharmacokinetics
-
Biosimilar Pharmaceuticals / therapeutic use*
-
Clinical Trials as Topic
-
Drug Approval / legislation & jurisprudence*
-
Drug Substitution
-
European Union
-
Humans
-
Infliximab / adverse effects
-
Infliximab / therapeutic use
-
Pharmacovigilance
-
Psoriasis / drug therapy*
-
Spain
-
Spondylitis, Ankylosing / drug therapy
-
Therapeutic Equivalency
Substances
-
Antibodies, Monoclonal
-
Biosimilar Pharmaceuticals
-
CT-P13
-
Infliximab