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