Strohl William R
Janssen BioTherapeutics, Janssen Research and Development, LLC, Pharmaceutical Companies of Johnson & Johnson, SH31-21757, 1400 Welsh and McKean Roads, PO Box 776, Spring House, PA, 19477, USA,
BioDrugs. 2015 Aug;29(4):215-39. doi: 10.1007/s40259-015-0133-6.
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(®) [a PEGylated, longer-half-life version of Neupogen(®) (filgrastim)] and Aranesp(®) [a longer-half-life version of Epogen(®) (epoetin-α)]. 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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