(AGI) - Rome, April 3. – "We must evaluate very positively some signs of the change in the image of biosimilar drugs both among political decision-makers and among opinion leaders. The fact that an important region like Campania decides to encourage the use of biosimilars, as well as generics, goes certainly in this direction". So the vice president of AssoGenerici Francesco Colantuoni after the publication of the Decree n. 27/2013 of the Campania president Stefano Caldoro. In fact, the text states that the biosimilar drug "represents an opportunity for rational use of resources, in the authorized indications, due to their greater economic convenience compared to the originator drugs", which, although having to proceed with caution with the substitution between the originator and biosimilar "for newly diagnosed or naïve patients, on the other hand, there are no reasons to advise caution in the use of biosimilars, which therefore represent an additional therapeutic option".
Finally, the decree recalls that biosimilar drugs, according to the data included in the National Pharmacovigilance Network (at Aifa), do not have a higher incidence of reports of suspected adverse reactions than the originators and that in any case there is no evidence of therapeutic ineffectiveness due to the use of biosimilar drugs". According to the vice president of AssoGenerici "the role of the biosimilar could not be better illustrated, also doing justice to those excesses of caution, unmotivated, which however never emerge when it comes to originator drugs , which also undergo changes in production processes using the same regulatory procedures in force for biosimilars". "Attitudes of this kind – he concludes – represent only a defense to the bitter end of the patent". For the president of AssoGenerici Enrique Hausermann "defend and protecting the fruit of research and innovation is fundamental for the progress of knowledge. However, and the recent Indian events also prove it, precisely for this reason a clear definition of the innovativeness of a drug must be drawn up and the defense of intellectual property must be tempered with the need to treat as many patients as possible possible while safeguarding the economic stability of health services". (AGI) .
03 Apr 2013
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