What is the difference between a generic and a biosimilar?

    A Generic is a chemically derived medicinal product, usually a simple, homogeneous small molecule, whose bioequivalence must be demonstrated. However, a Biosimilar is a medicinal product of biological origin, usually with a complex structure, and large proteins (such as antibodies) that are subject of heterogeneity. As a result of that heterogeneity, any variation must be […]

    A Generic is a chemically derived medicinal product, usually a simple, homogeneous small molecule, whose bioequivalence must be demonstrated. However, a Biosimilar is a medicinal product of biological origin, usually with a complex structure, and large proteins (such as antibodies) that are subject of heterogeneity. As a result of that heterogeneity, any variation must be assessed to ensure that there is no therapeutic consequence for the patient, and also the biosimilarity needs to be demonstrated through rigorous comparisons of efficacy and safety.
    Therefore, the regulatory requirements of the European Medicines Agency (EMA) for the development of biosimilars are more demanding than for developing generics.

    In general terms, you can find all the information available in EMA webpage http://www.ema.europa.eu/ema/

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