Biopharmaceuticals as Challenges to the Regulatory System

摘要: Biopharmaceuticals differ from small molecules in terms of structure and pharmacology. Furthermore, they are also prescribed for different patient populations. The protein nature biopharmaceuticals makes them especially prone immunological reactions their safety profile may be affected by seemingly minor changes the production process. This unpredictability concerns has triggered increased regulatory interest biopharmaceuticals, which as a result arrival competing version biopahrmaceuticals, so-called ‘biosimilars’. In thesis studied challenges to system, through analysis ability existing instruments deal with these issues. is divided three chapters covering themes: (1) mechanisms adverse events consequences risk management strategies, (2) posed biosimilars (3) strategies study processes. Novel pharmacovigilance tools have provided regulators new optimize biopharmaceuticals. We found that, despite clear differences post authoroziation between molecules, were not reflected source actions. knowledge that been gained being translated into facilitate management. Based on product, how it interacts its target, likely ADRs, carefully designed strategy taking case-by-case approach should determine optimal toolkit establish benefit European regulations outlining approval criteria place since 2005 then 14 biosimilar products received marketing authorization. Several questions remain about subject extensive authorization requirements. argue scope limited immunogenicity associated events. reviewed several data sources did identify switching within same class. develop oncology, order allow development monoclonal antibodies necessary novel endpoints comparability exercise. evaluated role periodic update reports (PSURs) monitor remains challenge contribution safe use medicines ancillary Furthermore we performed cost effectiveness PSUR reporting Europe. Our suggest unlikely costs outweighed health gains. conclude standard accompanied plan assess effects. present model instrumental gaining insight efficiency achieving predefined objectives performance and/or