> The biological generic is not perfect

Are the biosimilars, versions not the designer of biological medicinal products that have lost patent shopping, always più in the centre of the discussions of the scientists becauseè, in contrast to ‘classic’ generics, are not the exact photocopy of the original.

Doctors and pharmacists should, therefore, know them well to ensure the health of the patients, while the authoritiesà have to sì that the systems of approval and nomenclature to allow a classification and a use sure.

this is the parlerà tomorrow in Florence on the occasion of the conference on “Biosimilars: prospects comparison’ sponsored by the superior School of Oncology and biotechnological Sciences.

“it’s like when you produce a Chianti wine: the name is the same – he says to the Adnkronos Salute Francesco Costanzo, director of the Unità operating of medical Oncology at the azienda ospedaliero-universitaria Careggi of florence – but the grape used is always different and the result is never guaranteed nè identical to the better product”.

In the next few years an increasing number of patients curerà with drugs biotech: just think that today, one-third of the molecules during development is of biological origin. Medicinal products smart intended to treat serious diseases such as cancers, infectious diseases, and immune, cardiovascular, respiratory, and neurological.

However, the arrival of biosimilars poses doctors, and public administrators faced with the difficult problem of how best to use these drugs, protecting the health of the patients. “Europe is destined to face the ‘management’ of these products – underlines the expert – because; contrary to what happens in the United States, where patents expire after 10 years from the start of production of a drug, here we have the trade protection expire after 10 years from the registration of the product, therefore much earlier than the Usa.

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our Continent fungerà, therefore, on the test bench and will be under observation from across the atlantic”.

Page published on 19 may 2008