"By 2015, as many as 45 important biological drugs in Italy will lose their commercial exclusivity", opening up the market for biosimilar products, "for a value of approximately 500 million euros per year".
Giorgio Foresti, president of Assogenerici, the association of industries that produce equivalent medicines, made the balance yesterday in Rome on the sidelines of the meeting 'Biotechnological drugs and governance'. It will above all be medicines, recalled Foresti, "for the treatment of important pathologies, mostly oncological.
The use of the generic equivalent and the biosimilar makes it possible to generate resources for innovation: it is now in the public domain that biological medicines are and will be increasingly used for the treatment of disabling and risky pathologies for the patient's life, such as for example amyotrophic lateral sclerosis. But the treatment of these pathologies has a very high cost and will be accessible to many affected patients only when expenditure is rationalized by introducing biosimilar drugs".
The Tuscany and Campania Regions are the leaders in the introduction of regulations that facilitate the use of these products: "The former due to a long tradition of sensitivity towards this issue – highlighted Foresti – the latter due to needs linked to economic savings".
The fact is that the former has issued two measures (Decree 15/2009 and 44/2010) to encourage the use of biosimilars with an average savings target for treatment costs of at least 40%, while the latter intervened with a resolution ( 592 of 7 June 2010) which established that in public tenders only the composition, route of administration, therapeutic indications and any dosages must be indicated. "And their example – concludes Foresti – will soon be followed by Piedmont, Molise, Calabria and Lazio".
Barbara Di Chiara – March 25, 2011 – Pharmakronos
Soon Aifa-ministry document on biosimilars
"A sharing document signed by the Ministry of Health and Aifa should arrive shortly, which establishes the principle of therapeutic bioequivalence between biological drugs and biosimilars and therefore opens up to single tenders for public structures". This was announced by Giorgio Foresti, president of Assogenerici, in Rome on the sidelines of the meeting 'Biotechnological drugs and governance'. "Also in the light of what was established in the Antitrust report to the Parliament - continued Foresti - we await this document, which should recognize in all respects the principles
