Defining naïve patient for biological drug use is challenging

By William Chin, PhD, Scientific Coordinator, EUCRAF

A recent review entitled "The challenging definition of naïve patient for biological drug use" was published on the 31 Jan 2015 issue of Autoimmunity Reviews. The highlights of the review are as follows:

  • The Italian Medicines Agency (AIFA) stated that biosimilars cannot be considered interchangeable with originators.
  • The prescription of biosimilars is a clinical decision up to the prescribing physician.
  • AIFA considers biosimilars as a therapeutic option with an economic advantage in primary naïve patients with no previous exposure to the originator or with a sufficiently long wash-out period ("secondary naïve").
  • However the identification of "secondary naïve" is challenging.
  • The drug biologic effect (dependent on the type of biologics) and immunogenicity (trigger of anti-drug antibody response) can affect the wash out period needed to identify “secondary naïve” patients.


1. Autoimmun Rev. 2015 Jan 31. doi: 10.1016/j.autrev.2015.01.016. The challenging definition of naïve patient for biological drug use. Biggioggero M, Danova M, Genovese U, Locatelli F, Meroni PL, Pane F, Scaglione F.