In Europe, during 2021, 79 new medicines were authorised, of which 61 containing new active substances (25 orphan medicines for the treatment of rare diseases), 6 biosimilars and 12 equivalents.

Among the new medicines authorised by the European Medicines Agency (EMA), antineoplastic and immunomodulatory medicines, intended for the treatment of autoimmune diseases and certain types of solid tumours (such as lung, breast and uterine cancer) and blood cancers (such as myeloma, lymphoma and leukaemia), continue to dominate (40.5%),  followed by anti-infectives for systemic use (12.6%), medicines for the nervous system (7.6%) and for the digestive system and metabolism (7.6%); lower percentages concern new medicines in other ATC categories.

This is some of the information contained in the 4th edition of the Report "Horizon Scanning: incoming medicines scenario", published by the Italian Medicines Agency on its institutional website. The Report aims to provide information on new medicines and therapies that have received a positive opinion from the EMA in 2021 or may receive one in the following years.

Among the orphan medicines that have received a positive opinion from the EMA, two are advanced therapy medicines, specifically gene therapies: Abecma, for the treatment of adults with relapsed and refractory multiple myeloma, and Skysona, for the treatment of early brain adrenoleukodystrophy.

Based on the data available at the time of writing, 96 new medicines are expected to receive an opinion from the EMA by 2022, with antineoplastic medicines predominating, followed by a significant proportion of nervous and sensory system medicines, immunosuppressants and immunostimulants, and digestive system and metabolic medicines. Of the 29 orphan medicinal products currently under evaluation, seven are advanced therapy medicinal products.

The publication of the Report is part of AIFA's Horizon Scanning activities, aimed at identifying and evaluating at an early-stage new medicines and new therapeutic indications of already authorised medicines, which will expand the treatment options available to physicians and patients by filling unmet health needs.