Recent international studies and analyzes of pharmacovigilance data on biosimilars show results in line with the position taken and expressed by AIFA in its Second Position Paper.
Studies of scientific literature and new evidence together with data on use and pharmacovigilance confirm the efficacy of biosimilar medicines and the interchangeability with respect to their originator. The AIFA continuously monitors data from these sources to ensure patients have adequate treatment options in terms of efficacy, safety and quality.
Just yesterday a study was published in the Annals of Internal Medicine journal that demonstrated the equivalence in terms of safety and efficacy of a biosimilar of infliximab compared to the originator. Numerous analyzes published in the literature have compared the effects on patients of the transition from biological originator drugs to their biosimilars (the so-called “switch”), highlighting completely similar outcomes, with the same therapeutic indication.
The biosimilars thus confirm themselves as a valid tool to guarantee more health to patients with equal resources.
AIFA's mission to protect public health is also achieved by providing independent information, based on scientific data, clear and derived from verifiable sources for the benefit of patients and healthcare professionals.
