Biologics, Biosimilars and Patents: A Beginner's Guide

Given the recent history of the BPCIA and the ongoing understanding of how the regulatory aspects are working in practice, including the multiple types of biologic products that are covered by the law, it can seem quite a complicated system for those not in the business. It is with this in mind that we created this beginners guide to provide an entry point for those who want to learn more about how the biologics regulatory system works for biosimilar drugs and its intersection with the patent system.