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Biosimilars, same tests as the originator drugs in the EU

Biosimilars are medicines which, in order to obtain this status, must demonstrate quality, safety and efficacy equal to the originators and validated through a regulatory procedure that can be superimposed in terms of rigor and completeness and with identical controls on materials and production technologies. This is stated in the Guiding principles promoting good governance in the pharmaceutical sector, a consensus document drawn up by the European Commission as part of a project on corporate social responsibility. The document reiterates that the rules on substitutability and interchangeability between the originator biotech drug and the biosimilar remain the responsibility of the individual states, but underlines that the process for authorization must go through the same exact checks. "The conclusions of the document," he comments Michael Uda, general manager of AssoGenerici «go to confirm the goodness of the approach adopted since the beginning by the producers of Italian biosimilars: an approach that is based on the continuous scientific exchange with the medical community and in the work of information on the characteristics of these medicines and on the concrete possibilities of maintaining high standards of care even in a phase of limitation of available resources and constant growth of hospital pharmaceutical expenditure». And precisely on the accessibility of treatments, the document underlines the fundamental role of these medicines in expanding the number of patients who can access these treatments! and, hitherto limited by the economic compatibility of health services.

April 24, 2013 – DoctorNews33





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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco