L'avvento dei biosimili: nuove regole per garantire la sicurezza del paziente.

Translated title of the contribution: [The advent of biosimilars: new rules to guarantee patient safety].

L. Gesualdo, M. P. Abbracchio, F. Dammacco, F. Goffredo, A. Zanella, C. Ronco

Research output: Contribution to journalArticle

Abstract

Biosimilars are medicinal products proposed as copies of biotech drugs whose patents have expired. Their entry into the therapeutic armamentarium entails knowledge of the rules established in Europe relevant to their use in clinical practice. In September 2007, an Italian panel of experts comprising two nephrologists, a clinical immunologist, an oncohematologist, a pharmacologist, and a hospital pharmacist examined the main features of biotech drugs and the issues faced by the regulatory authorities in the definition of a specific approval pathway for biosimilars in Europe. The panel of experts agreed that it is important to inform the medical and scientific community that biosimilars are not exact copies of their reference products; therefore the rules governing their clinical use are not the same as those established for biotech drugs in general. Patient safety should be the fundamental principle guiding therapeutic choices, and making these choices should be the prerogative of physicians.

Original languageItalian
Pages (from-to)161-170
Number of pages10
JournalGiornale italiano di nefrologia : organo ufficiale della Società italiana di nefrologia
Volume26
Issue number2
Publication statusPublished - Mar 2009

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ASJC Scopus subject areas

  • Nephrology

Cite this

Gesualdo, L., Abbracchio, M. P., Dammacco, F., Goffredo, F., Zanella, A., & Ronco, C. (2009). L'avvento dei biosimili: nuove regole per garantire la sicurezza del paziente. Giornale italiano di nefrologia : organo ufficiale della Società italiana di nefrologia, 26(2), 161-170.