Journal
BIODRUGS
Volume 29, Issue 4, Pages 215-239Publisher
ADIS INT LTD
DOI: 10.1007/s40259-015-0133-6
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The purpose of making a biobetter biologic is to improve on the salient characteristics of a known biologic for which there is, minimally, clinical proof of concept or, maximally, marketed product data. There already are several examples in which second-generation or biobetter biologics have been generated by improving the pharmacokinetic properties of an innovative drug, including Neulasta (R) [a PEGylated, longer-half-life version of Neupogen (R) (filgrastim)] and Aranesp (R) [a longer-half-life version of Epogen (R) (epoetin-alpha)]. This review describes the use of protein fusion technologies such as Fc fusion proteins, fusion to human serum albumin, fusion to carboxy-terminal peptide, and other polypeptide fusion approaches to make biobetter drugs with more desirable pharmacokinetic profiles.
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