In view of the impact that the cuts in healthcare in the Lazio Region will have on the ability to better treat cancer patients, biosimilar drugs of monoclonal antibodies are a resource to contain costs. The 52% of the Lazio oncologists of Aiom (Italian Association of Medical Oncology) is convinced of this, having conducted a survey among 300 of its members in the Region, to which about half responded. The results were presented during the seminar "Biosimilars from monoclonal antibodies in oncology", held in recent days in Rome at the Regina Elena and sponsored by Sifo (Italian Society of Hospital Pharmacy) and Sif (Italian Society of Pharmacology). In Lazio, cancer causes 26,000 new diagnoses and about 11,400 deaths each year (2010 estimates). «Biosimilars have now entered clinical practice, in particular with regard to erythropoietins and growth hormones» he explains Stefano Cascinu, president Aiom. "Currently there are four molecules on the market and in the next few years biosimilars of monoclonal antibodies will also be available". In view of the forthcoming introduction of these drugs, Aiom, a note reads, intends to promote a debate on this issue: "Opportunities must be seized to save resources and facilitate access to new drugs" continues Cascinu and underlines: "We ask that the evaluation of biosimilars by the regulatory authority is developed on typical endpoints of already registered drugs. We would also like the safety and tolerability of these products to be clear". According to the oncologist, in fact, the extension of use of biosimilars for indications other than those envisaged in the registration dossier could be inadequate in oncology: "Each new therapeutic indication should therefore be subjected to a specific registration procedure". For the 39% of the oncologists from Lazio, in fact, the critical issues in the use of biosimilars derive from the fact that they can function in a different way than the originator, and the 70% asks to decide on substitutability.
April 22, 2013 – DoctorNews33
