REPORT - Biologic Innovation, Quality & Reliability

BIOSIMILARS TRENDS IN2 015 REPORT2 MESSAGE FROM AmgenMESSAGE FROM EDITORIAL COUNCILINTRODUCTION & EXECUTIVE SUMMARYPAYER PERCEPTIONS OF BIOSIMILARSPAYER READINESS FOR BIOSIMILARSPAYER EXPECTATIONS OF PRICE & ACCESS AS CENTRAL VALUE DRIVERS FOR BIOSIMILARSLOOKING AHEADGLOSSARY4581220364648 TABLE OF CONTENTS3 WHAT ARE BIOLOGICS AND BIOSIMILARS? A Biologic medicine is a large molecule derived from living cells that is used to treat or prevent disease, such as a therapeutic protein, DNA vaccine, monoclonal antibody ( , MAB) or fusion These medicines are far more complex than small molecule drugs and are highly sensitive, making them more difficult to characterize and As more is learned about the biological mechanisms of diseases, new Biologic medicines can be developed that target the causes of disease, potentially altering the course of disease

3. WHAT ARE BIOLOGICS AND BIOSIMILARS? A biologic medicine is a large molecule derived from living cells that is used to treat or prevent disease, such as a therapeutic protein, DNA vaccine, monoclonal antibody (i.e., MAB) or fusion

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