What is the procedure to authorize a biosimilar in the European Union?

    Like all medicines, a biosimilar medicine needs to receive a marketing authorisation before it can be commercialised. Biosimilars are approved by the European Commission (EC) through a European centralized procedure, which is overseen by the EMA. There are several kinds of medicines that must be approved by centralized procedure, such biological products, medicines for diabetes, […]

    Like all medicines, a biosimilar medicine needs to receive a marketing authorisation before it can be commercialised. Biosimilars are approved by the European Commission (EC) through a European centralized procedure, which is overseen by the EMA.

    There are several kinds of medicines that must be approved by centralized procedure, such biological products, medicines for diabetes, medicines for cancer, medicines for AIDS, medicines for orphan disease…
    The centralized procedure consists in one submission, one assessment by CHMP, one decision by EC and one authorization valid for all the countries of EU, Norway, Iceland and Liechtenstein.
    As is the case for all medicines, European regulations and guidelines are in place to ensure the quality, safety, and efficacy of biosimilar medicines, as well as to avoid unnecessary clinical testing. One key aspect to be considered is the variation of potency and purity of the product, which should be within the limits displayed by the reference product.

    Due to the production and structural complexity of biological/biotechnology-derived products, in 2005 the EMA pioneered the issurance of a regulatory pathway specifically designed to guide the development of potential biosimilars. The similar biological medicinal products approach is based on a very demanding comparability exercise. Comparability studies between the biological reference medicinal product (original product) and the potential biosimilar are needed to provide evidence supporting the similar nature, in terms of quality, safety and efficacy, of the new similar biological medicinal product and the chosen reference medicinal product authorised in the EU. In addition to quality and preclinical studies, head-to-head comparability clinical trials between the original product and the intended biosimilar in healthy volunteers and patients are usually required. Demonstration of biosimilarity does, therefore, include phase III trials.

    Once the medicine is approved, specific monitoring is required for biopharmaceuticals to ensure their long-term safety and efficacy. In addition to specific monitoring, data is collected through pharmacovigilance programs. This data is used to prepare periodic safety update reports (PSURs), which summarise the risk-benefit of a given medicine at frequent intervals, both after the product is first approved and then after it has been marketed.  For further information, please see our section of guidelines of the EMA

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

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