Biosimilars in Dermatology: Current Situation (Part I)

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 article, we review regulatory issues related to the approval of biosimilars, with a particular focus on the situation in the European Union. We will examine analytical characterization studies and special considerations for clinical trials with biosimilars, and also look at several somewhat contentious issues, such as the extrapolation of indications, interchangeability, and automatic substitution. Finally, we will 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.