• Feature ArticlesFeature Articles

    What are biosimilars and why are they important?

    This article provides an overview of biosimilars and explains their benefits, similarities to “reference” biologics, clinical applications and recent regulatory challenges. It is intended to provide a top-level introduction to regulatory professionals who have a limited awareness of or are new to biosimilars. Introduction Biosimilar medicines are no novelty, they have been around for more than a decade. The first biosimilar approved in Europe was Sandoz’s somatotropin b...
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    Medicinal Product Registration in Egypt

    This article provides an overview of Egypt's New Drug Application (NDA) procedure for imported brand pharmaceutical products, including new chemical entities and biologics. It discusses the various Egyptian Drug Authority (EDA) departments and the required procedures for moving products through registration and into the market. Introduction Egypt, with more than 92 million inhabitants, is the most highly populated nation in North Africa and the Arab world. It is the t...