A meeting organized by the Italian Medicines Agency (AIFA) entitled “Access to therapies with biological drugs: the phenomena of under treatment and the opportunities offered by “biosimilars” was held in Rome on Tuesday 27 March, with the aim of discussing the opportunities that these drugs can offer the National Health System in terms of maintaining the balance between the need to contain spending and the protection of patients’ rights. During the meeting the “Second Position Paper on Biosimilar Drugs” was also presented, which expresses the position of AIFA on the subject.

Professor Silvio Danese, Head of the Centre for Inflammatory Bowel Diseases at Humanitas and Professor at Humanitas University, was present as moderator in the field of Gastroenterology.


What are biological drugs?

Biological medicines are obtained from living organisms, such as living cells, which are modified by the biotechnologies available today. This process allows these living cells to produce the active ingredient of the biological drug. The development of these drugs began in the 1980s and there are currently several biological drugs available to treat cancer and autoimmune diseases, for example.


What are bio-similar drugs?

Bio-similar drugs are “very similar” to biological drugs and can only be put on the market once the patent for the existing biological drugs they are based on has expired.

Biosimilars cannot be considered identical to biological ones because they are composed of living organisms and therefore they necessarily differ in the active principle, even if only minimally. That is why they are called “extremely similar”. Certain variability is typical of all biological drugs, just for the use of live cells; it is thought that even the smallest differences between one batch of the same biological drug and another can be detected.

Biosimilars are, however, subject to in-depth scientific evaluations in order to ensure their safety and efficacy before they are placed on the market.


What is AIFA’s position expressed in the Second Position Paper on Bio-similar Drugs?

“Bio-similar medicinal products shall be approved to the same standards of quality, safety and efficacy as are required for any biological medicinal product and shall be subject to a rigorous evaluation process. The risk-benefit ratio is, in fact, the same as that of the reference originators: this is why AIFA considers them interchangeable. However, it will be the doctors who will have to assess its use.

Biosimilars are an essential tool for the development of a competitive market that produces health because they are a therapeutic option at a lower cost for the National Health Service. This means treating an increasing number of patients and guaranteeing access to therapies with a high economic impact, with potential savings not only in terms of health costs, but also in social costs”, said Mario Melazzini, AIFA General Director, during the meeting.

This is a historical position taken by AIFA that for the first time expressly speaks of interchangeability between biological and bio-similar drugs, while leaving the decision between one and the other in the hands of doctors of reference.


The work during the meeting and the presence of professor Danese

The day was organized in thematic working groups, dedicated to investigating the impact of medicines in specific clinical areas: Rheumatology, Gastroenterology, Dermatology and Oncology.

Moderator for Gastroenterology was professor Danese, who commented on the novelty: “A fundamental finding that emerged is that of the under-treatment of patients with Crohn’s disease and ulcerative rectocolitis. It is estimated that in Italy at least 20% of patients do not receive appropriate therapies and biosimilars certainly represent an effective strategy to maintain access to innovative therapies, contributing to the containment of costs”.