The First Biosimilar Epoetin

Abstract

Reducing health costs is a hot political issue in many countries, so the introduction and use of generic drugs is stimulated. The generics may be introduced when the patent of an innovative drug expires. With classic drugs, normally produced by chemical synthesis, only limited data for marketing approval application are needed compared with the original drug (1). The generic manufacturer needs to submit data showing the generic to be chemically identical to the innovative drug and pharmaceutically acceptable. In addition, the bioavailability of the generic product must be shown to be equivalent to that of the reference product. This is assessed by pharmacokinetic studies demonstrating an equivalent rate and extent of absorption, typically conducted in healthy volunteers. If the pharmacokinetic parameters such as area under the drug plasma concentration-time curve (AUC) and maximum observed plasma concentration (Cmax) fall within the range of 0.80 to 1.25 (90% confidence interval), the products are considered bioequivalent. These requirements are based on the assumption that products that demonstrate an identical pharmacokinetic profile will also have identical clinical effects. The randomized clinical trials required for the approval of new products to demonstrate safety and efficacy are not necessary for the approval of conventional generics. So the clinical data generated with the original product can be extrapolated to the generic. This generic paradigm, made possible by the availability of sophisticated methods for analysis, has resulted in generic products that are safe and effective. Companies marketing a generic product do not need to spend the large investments necessary to develop and launch an innovative drug. They do not need to develop markets and can rely on the extensive experience and expansion of the indications that the innovator may have achieved during the period in which the drug's patent was protected. So the price of a generic …