doi: 10.1093/ndtplus/sfn177 Biosimilar therapeutics—what do we need to consider?

Patents for the first generation of approved biopharma-ceuticals have either expired or are about to expire. Thus the market is opening for generic versions, referred to as ‘biosimilars ’ (European Union) or ‘follow-on protein prod-ucts ’ (United States). Healthcare professionals need to un-derstand the critical issues surrounding the use of biosimi-lars to make informed treatment decisions. The complex high-molecular-weight three-dimensional structures of biopharmaceuticals, their heterogeneity and dependence on production in living cells makes them dif-ferent from classical chemical drugs. Current analytical methods cannot characterize these complex molecules suf-ficiently to confirm structural equivalence with reference molecules. Verification of the similarity of biosimilars t