title: Fusion Proteins for Half-Life Extension of Biologics as a Strategy to Make Biobetters.
abstract: 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.
authors.affiliation: 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, wstrohl@its.jnj.com.
authors.forename: William R
authors.initials: WR
authors.lastname: Strohl
mesh_terms: D000818:Animals; D001688:Biological Products / Q000737:chemistry / Q000493:pharmacokinetics*; D002626:Chemistry, Pharmaceutical / Q000379:methods; D015195:Drug Design; D006207:Half-Life; D006801:Humans; D010455:Peptides / Q000737:chemistry / Q000493:pharmacokinetics; D011993:Recombinant Fusion Proteins / Q000737:chemistry / Q000493:pharmacokinetics*; D012709:Serum Albumin / Q000378:metabolism
chemical_list: D001688:Biological Products; D010455:Peptides; D011993:Recombinant Fusion Proteins; D012709:Serum Albumin