Progress and Hurdles for Follow-on Biologics

From the New England Journal of Medicine

By Ameet Sarpatwari, JD, PhD; Jerry Avorn, MD; Aaron S. Kesselheim, MD, JD, MPH

SUMMARY: This NEJM Perspective evaluates the early progress of the biosimilar approval pathway created by the 2010 Biologics Price Competition and Innovation Act (BPCIA). Sarpatwari, Avorn, and Kesselheim mark the FDA's first biosimilar approval — filgrastim-sndz — as a milestone, while identifying the significant legal, regulatory, and market obstacles that threaten to limit biosimilar uptake and the expected cost savings. The piece examines the patent thickets, interchangeability standards, naming conventions, and prescriber-education challenges that complicate the biosimilar market relative to traditional small-molecule generic drugs. The authors argue that the challenges, while large, are not insurmountable, and identify specific policy interventions that could accelerate biosimilar competition.

BACKGROUND: The 2010 Biologics Price Competition and Innovation Act created a new FDA regulatory pathway for biosimilar drugs — follow-on versions of complex biologic medicines — modeled on the Hatch-Waxman Act's generic drug framework.

KEY FINDINGS: The FDA approved its first biosimilar, filgrastim-sndz, under the BPCIA pathway. However, patent thickets, interchangeability requirements, naming conventions, and market dynamics create hurdles to widespread biosimilar adoption and price savings.

IMPLICATIONS: Policy interventions targeting patent gaming, prescriber education, and interchangeability designations could accelerate biosimilar competition and reduce the cost of biologic medicines for patients.