Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product

    #640916

    IATE #2250149
    leigheas bithchosúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    biosimilar medicinal product | biosimilar | similar biological medicinal product | similar biological | biosimilar medicine | biogeneric
    en
    Definition biological medicine highly similar to another already approved biological medicine (the ‘reference medicine’) Reference "COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products"
    Comment Unlike the small molecules of classical medicines, which are ‘chemically’ synthesised, the much more complex biosimilars are extracted or synthesised from biological sources such as blood or tissues, and for this reason cannot be fully identical to their reference products.
    biosimilaire | biogénérique | médicament biologique similaire
    fr