[Biosimilars: regulatory status for approval]

A Herrero Ambrosio
Farmacia Hospitalaria 2010, 34 Suppl 1: 16-8
Biotecnological drugs represents the future treatment in medicine. Since the expiry of the patent of the fi rst approved biotech drug, "copying" and marketing of them can be offered by any other biotech company, these new medicines are known as biosimilar medicines. They are approved by the EMEA (European Medicines Evaluation Agency) through the European centralised procedure, the EMEA issued several stringent guidelines to approve a biosimilar drug on the European market, preclinical and clinical studies are necessary to asses the highest standards in quality, efficacy and patient safety. The World Health Organization has determined that biosimilar have the same INN than the original product.

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