Strategies for Biogeneric Success

Abstract

This paper discusses the nature of generic biopharmaceutical products and the barriers to their entry into the market. It reaches the conclusion that there are substantial rewards to be had for the first company to be successful, but that market entry may take longer than many observers think. To be successful, a company must be able to make the product to the required quality standards, to navigate the emerging regulatory pathways successfully and to market the product effectively. In each case the challenge is different, and more complex, than that facing synthetic generic products.