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Course Discription |
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This course is concerned with biological drugs, their definition, techniques used in their production and purification, and their therapeutic applications. In addition, it discusses the definition of biosimilars and the guidelines developed by different agencies such as the European Medicines Agency (EMA), the World Health Organization (WHO) and the Food and Drug Administration (FDA), as well as the approval requirements and type of testing required for biosimilarity. In addition, this course covers topics related to innovation, patents and biologics: The road to biosimilar competition: factors in?uencing investment, Business Decisions and Marketing of Biosimilars. |