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]

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.

Publication types

  • Review

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