A comprehensive guide to the three biosimilar markets (Europe, US, Japan) and the regulatory pathways

Abstract

Generics in the pharmaceutical industry have been instrumental in reducing overall healthcare cost and allowing for greater dispersal of life saving drugs to the general population. The Hatch-Waxman Act of 1984 played a critical role in changing the landscape of the pharmaceutical industry and providing legislation for an abbreviated regulatory pathway for generic drugs. The conversation has shifted to the need to implement similar regulatory paths for generics of biologics. First generation biologic patents have or are geared to expire within the next five years, providing a great opportunity for generic companies in this space to enter. Biologic generics, termed biosimilars or follow-on biologics, are more difficult to evaluate due to the complex nature of the molecule and the variables involved in the development and manufacturing process. This research seeks to understand the current debate in the biosimilar conversation, and examine whether there is a clear regulatory path to market for biosimilars using epoetin as a case example across the three main markets; US, Europe and Japan.