"Biosimilar medicines are an important therapeutic resource and an opportunity to help ensure more and more the response to the emerging health need. In synergy with biological drugs, they can provide answers to the problem of undertreatment for many pathologies, guaranteeing access to treatment to an ever greater number of patients, "said the Director General of the Italian Medicines Agency, Mario Melazzini, on the sidelines of meeting "Access to therapies with biological drugs: the undertreatment phenomena and the opportunities offered by biosimilars" organized by the Agency today in Rome.
During the event, the Second Position Paper on Biosimilar Drugs was presented, which presents the official position of the Agency on the use of these non-equivalent drugs but "similar" to biological reference medicines no longer subject to patent protection. .
"Just as many biological drugs approach the patent deadline", added Melazzini "AIFA wanted to release this Position Paper to clarify the scientific, regulatory and regulatory aspects concerning biosimilar medicines. This category of medicines is in fact similar to the biological reference products of reference for efficacy, quality and safety and with respect to which they have the same benefit-risk ratio ".
"The AIFA Position Paper", the General Manager concluded, "is also a tool for awareness and cultural stimulation and enables healthcare professionals to provide the correct information to the patient about the characteristics of these drugs and to contribute to the sustainability of the National Health System" .
For AIFA, biosimilars are therefore an indispensable tool to ensure timely access to innovative therapies in areas such as oncology, rheumatology, gastroenterology and dermatology, responding to the ever-increasing demand for health.
These medicines contribute to the creation of a competitive organic market and benefit in helping to maintain a balance between pharmaceutical spending and protecting patients' rights.