Competition concerns in the ex-patent biological medicines market : an European perspective

Abstract

Biological medicines are the future of pharmacology and medicine. They derive from a/nbiological source (a typical example being insulin) and those which are ex-patent, together with their copies –which are called “biosimilar medicines”-, conform the ex-patent biological medicines market./nThe study of such a market reveals two issues: First, that although market shares of the main players of the industry do not show a problematic level of concentration (when looking at the aggregate of all medicines), high concentration levels do appear when subdividing the market for each drug. Second, that although the entry of biosimilars reduces market shares for branded biological medicines (also decreasing their prices), a different impact will be observed depending on the country./nThe study suggests, thus, that there are competition concerns in the market, and to address them it is proposed to use legislation, creating common principles for the development and testing of biosimilars at a global level (facilitating international competition), setting an abbreviated pathway for biosimilars’ commercial approval (when they are already marketed outside Europe), giving biosimilars and their reference products the same International Non-Proprietary Name (so as to eliminate the perception of differences) and allowing interchangeability and substitution by law.