Recently, the Italian Medicines Agency (AIFA) has published a new Concept Paper on Biosimilars. The Concept Paper outlines the regulatory status of biosimilars in Italy as well as their importance for the Italian healthcare sector.
The new Concept Paper constitutes a revision of AIFA’s Position Paper on Biosimilars of 13 May 2013. Overall, the Concept Paper does not differ significantly from the Position Paper of 2013. In fact, both Papers indicate that it is for the physician to decide on a case-by-case basis whether to treat a patient with a biosimilar or with the innovative biologic. They also exclude the automatic substitution between biosimilars and their originators. Continue Reading