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This handbook provides information on the current state of biosimilar medicines in the EU. It describes the science and technology behind biosimilar medicines, how they are produced and regulated, and provides answers to many specific questions. These include the terminology used, the meaning of “quality, efficacy and safety” and “comparability,” the purposes and methodologies of nonclinical and clinical tests and trials, the role of pharmacovigilance and risk management, and the significance of immunogenicity. Access to medicines, including substitution, interchangeability, and the importance of identification is also included.⁶²