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• W2262409806 abstract "Biosimilars are biological products that are very similar, but not identical, to an originator product. For anti-TNF biosimilars for inflammatory bowel disease treatment, a number of concerns have been raised by pharmacologists and gastroenterologists with respect to the evaluation of biosimilarity, product stability, production condition stability, biosimilar name, extrapolation of indications, traceability, interchangeability and pharmacovigilance. These points will be discussed in this review. There are several questions that have not been satisfactorily answered so far, leading to different regulatory guidelines in Europe (European Medicines Agency), the USA (Food and Drug Administration), Canada and other countries. For clinicians, it will be important to have knowledge about these concerns to make reasonable patient-oriented decisions in the upcoming confusing market of biosimilars for established anti-TNF antibodies." @default.
• W2262409806 created "2016-06-24" @default.
• W2262409806 creator A5058012401 @default.
• W2262409806 date "2015-07-02" @default.
• W2262409806 modified "2023-10-16" @default.
• W2262409806 title "Potential Concerns and Questions" @default.
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• W2262409806 doi "https://doi.org/10.1159/000381581" @default.
• W2262409806 hasPublicationYear "2015" @default.
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