CLOSE By continuing to browse the site, the user accepts the use of cookies on our part. More information. PRESS ROOM | JOB OPPORTUNITIES | IN THE COMMUNITY ITA - Italian PRODUCTS AND SERVICES ASSISTANCE ABOUT HOSPIRA BIOLOGICAL DRUGS About Hospira Biosimilars E-mail Print WHAT ARE BIOLOGICAL AND BIOSIMILAR DRUGS? A wide range of medicinal substances are produced in living cell systems using biotechnology. There is no universally recognized name for these products, but they have been described using terms such as biopharmaceuticals, biologics, and, as on this website, biologics. Biological therapies have revolutionized the treatment of a range of pathological conditions in numerous therapeutic areas, including oncology, rheumatology and diabetes. Biosimilars are successors of biological reference products (i.e. originators), which are produced once the patents relating to such reference products have expired (Figure 1). The introduction of biosimilars has increased the number of treatment options available to healthcare professionals, providing them with cost-effective treatment options with a host of additional benefits and features. THE DEVELOPMENT OF A BIOSIMILAR In order to develop a biosimilar, its comparability with the reference product must be demonstrated. This requires several years of clinical trials and trials in order to meet the stringent criteria required for marketing authorization. This is to ensure that there are no significant differences in quality, efficacy and safety between a biosimilar and its reference biological. Figure 1. Comparison between biologicals and biosimilars Adapted from Biosimilars Handbook, European Generic medicines Association, 2011 TO KNOW MORE Biosimilars and generic drugs Regulatory process of biological drugs Production of biological drugs Biological drugs Hospira LEGAL INFORMATION PRIVACY POLICY COMPLIANCE This site and its information are for the exclusive benefit of residents of Italy. Regulatory requirements, data requirements or medical practices may differ from one country to another. Therefore, the data on this site may prove unsuitable for use outside of Italy. The content of the site is intended for information purposes only and is not intended as a substitute for consulting a healthcare professional. If you have any questions about this site, please contact Hospira .