The difference between generic drugs and biosimilars

This article first appeared as a contribution to the 'Key Opinion Leader' series produced by Panacee Conseil.

My journey with biosimilars started when I became director of science & education at the European Association of Hospital Pharmacists in 2002, and soon thereafter assumed responsibility for the association's journal, European Journal of Hospital Pharmacy (EJHP). It was at that time that patents of key biological medicines like growth hormone, epoetin, and filgrastim were due to expire and became available for copying.

Around the same time, Johnson & Johnson reformulated its epoetin product Eprex, which some time later was linked to an increased occurrence of PRCA (pure red cell aplasia), a rare formation of antibodies to erythropoietin. The medical community was alarmed that a change in the formulation of a biological medicine might actually result in a detrimental side effect in patients. What could be the consequences if reverse-engineered copies were to be used in patients?