What is a biosimilar?

    The European Medicines Agency (EMA) defines a biosimilar or a similar biological medicinal product as “a medicinal product which is similar to a biological medicinal product that has already been authorised (the ‘biological reference medicinal product’). The active substance of a biosimilar medicinal product is similar to that of the biological reference medicinal product. The […]

    The European Medicines Agency (EMA) defines a biosimilar or a similar biological medicinal product as “a medicinal product which is similar to a biological medicinal product that has already been authorised (the ‘biological reference medicinal product’). The active substance of a biosimilar medicinal product is similar to that of the biological reference medicinal product. The name, appearance and packaging of a biosimilar medicinal product may differ from those of the biological reference medicinal product. It may also contain different inactive ingredients”. The pharmaceutical form, strength, and route of administration of the similar biological medicinal product should be the same as that of the reference medicinal product.

    The active substance of a similar biological medicinal product is a known biological active substance that is similar to the one of the reference medicinal product.

    A similar biological medicinal product and its reference medicinal product are expected to have the same safety and efficacy profile and are generally used to treat the same conditions.

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

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