Biosimilarprodukter - billigare version av biologiska läkemedel. Ger nya möjligheter inom flera terapiområden
Engelsk titel: Biosimilar products - cheaper version of biological drugs. New possibilities within several therapeutic fields
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Författare:
Mellstedt H
Email: hakan.mellstedt@karolinska.se
Språk: Swe
Antal referenser: 20
Dokumenttyp:
Översikt
UI-nummer: 09061832
Sammanfattning
Biosimilars are biological drugs that are considered to be similar to their corresponding reference product, but this does not mean that they are therapeutically interchangeable. There is a strong link between the manufacturing process for a biological medicine - which is, in principle, impossible to duplicate - and the properties of the end-product. Biosimilars are not generic copies of biological medicines but new and unique products approved on the basis of relatively limited clinical data. It is important to examine efficacy and safety issues associated with biosimilars and ensure adequate training for medical professionals and pharmacists. There are numerous original biological products on the market for which biosimilars have recently been approved or are about to be. Their introduction may result in cost savings, which may increase access to medicines and stimulate research and development.