Search for Amgen Italy PRESSROOM WORK WITH US WHO WE ARE RESEARCH THERAPEUTIC AREAS SOCIAL RESPONSABILITY Biosimilars HOME RESEARCH BIOSIMILARS Our commitment to biosimilars Amgen was one of the first companies to recognize the potential of biotechnology for the development of vital medicines for patients. Today, we are applying this thirty years of experience also in the development of biosimilars, without losing sight of our primary objective of making the most innovative drugs available to patients. The development and production of a quality biosimilar requires considerable know-how in terms of biotechnology, adequate infrastructure and major investments. Amgen has enlisted the best researchers and invested the necessary resources, over $ 1 billion, to develop its portfolio of biosimilars for the treatment of some of the most complex diseases. We work with multiple partners to increase our ability to capitalize on innovations and bring tangible benefits to those with serious medical conditions. Biosimilars have the potential to expand patient access to important therapies and we are bringing our best-in-class knowledge into this new area. The Development of Biosimilars Lo sviluppo di un biosimilare richiede una manodopera altamente qualificata, un processo multi-step e una profonda conoscenza del prodotto di riferimento (originator). Chi produce biosimilari esegue due percorsi contemporaneamente – il primo per comprendere l'originator e il secondo per la creazione, la selezione e la produzione del farmaco biosimilare. Questi percorsi si intersecano reciprocamente durante tutto il processo di sviluppo. Attributi critici di qualità Una profonda comprensione degli attributi critici di un originator – come per esempio sicurezza, efficacia e farmacocinetica (cioè l'assorbimento, la distribuzione, il metabolismo e l'eliminazione di un farmaco) - è fondamentale per produrre un biosimilare di alta qualità. Critical attributes include structures that are determined by DNA, cell line and the manufacturing process. Understanding the important attributes for each function and for each product is critical to achieving the best possible match between biosimilar and originator and ensuring that they have the same biological function for each patient. RESEARCH Research and Development strategy Pipeline Clinical Studies Introduction to biotechnology Production Biosimilars Who we are In short Mission and Values Amgen in Italy Awards and Acknowledgments How we operate Research Research and Development strategy Pipeline Clinical Studies Introduction to biotechnology Production Biosimilars Therapeutic areas Medical Information The safety of drugs Social responsability Partnership Amgen Foundation Pressroom Work with us Contact us Contacts © 2021 - Amgen Inc. Tutti i diritti sono riservati. Amgen S.r.l., Via Enrico Tazzoli 6 – 20154 Milano (Italia). Partita IVA e Codice Fiscale 10051170156 – sottoposta alla Direzione ed al coordinamento di Amgen Inc. ai sensi dell’art. 2497 Codice Civile Termini e Condizioni Informativa sulla privacy