A patient-centred paradigm for the biosimilars market

Abstract

Intr oduction In the history of medicine, biologicals are relatively new products. Biologicals developed in the 1980s produced an impact in nephrology, oncology, and other therapeutic areas. The expiration of intellectual property rights on originator biologicals created the possibility for development of ‘follow-on biologic’ products, based on the originators. The EU in 2005 initiated public discussion on guidelines for approval of such products [1], which it denominated as ‘similar biological medicinal products’ in the guideline but also referred to as ‘biosimilars’ in subsequent publications [2]. EMA approved its first biosimilar under these guidelines in 2006. Since then, many countries on all continents (besides Antarctica) have adopted similar biosimilar regulatory approval procedures, and the WHO has developed a guideline for development of such regulatory guidelines. Regulatory and industry conferences have addressed how to achieve the appropriate level of regulation for biosimilars [3]. One consulting company recently estimated the combined annual growth rate of the global biosimilars market at 52% for the time period 2010–15 [4].