AIFA Publishes “Second Concept Paper” on Biosimilars

June 15, 2016

On June 15, 2016, AIFA (the Italian Medicines Agency) published a “Second Concept Paper” on the use of biosimilars within the National Health System (NHS). The document is intended to start a discussion that should eventually lead to an amended or new version of the agency’s Position Paper of 28 March 2013 on the same topic.

No material changes are proposed by AIFA as to the general principles. However, the agency seems to want to open the door for a more frequent use of biosimilars also for non-naive patients. The Second Concept Paper now proposes that the “biosimilar is a therapeutic option whereby the risk-benefit ratio is the same as for the corresponding original biological product of reference, as it is proved by the regulatory assessment procedure for the authorisation. Such considerations apply also to the patients under treatment, where the opportunity of the change is left to the clinical appreciation of the physician.

Comments on the Second Concept Paper are due by September 15, 2016.