Report

Blockbuster Biologics Review | Issue 30

March 2026

Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges and patent litigations implicating blockbuster biologics and legislative proposals related to biosimilars in Q1 2026. We will continue to monitor developments in these post-grant challenges and litigations and provide you with regular updates.

Read the full report >>

BiologicsPost-Grant Challenges and Litigations
In this section, we break down post-grant challenges and Biologics Price Competition and Innovation Act (BPCIA) litigations, including the types of claims being challenged, the number filed each year, and their outcome. Notably, the current institution rate for inter partes review (IPR) challenges to patents that claim biologics—excluding IPRs that have settled or otherwise been terminated—stands at 57%.
> Download this section

BiologicsFDA—Biosimilar Approvals
This section tracks all US biosimilar approvals. The number of approved US biosimilars is 82, with the most recent approvals being Nufymco® (ranibizumab-leyk), Boncresa® and Oziltus® (denosumab-mobz), and Filkri® (filgrastim-laha).
> Download this section

BiologicsLegislative and Regulatory Updates
In this section, we highlight a report recently released by Bill Cassidy (Chair of the US Senate Health, Education, Labor and Pensions Committee) proposing legislative and regulatory reforms to modernize the FDA, including reducing certain data requirements for biosimilar approval and creating a new biologic approval pathway that is a hybrid between a full 351(a) biologic application and a 351(k) biosimilar application.
> Download this section

BiologicsSupporting Documents
This section provides a product-by-product breakdown of biologics-related patents that have been subject to an IPR, including the challenged claims.
> Download this section

View all past issues of Blockbuster Biologics Review >>

For more information, contact authors Christopher J. Betti, Ph.D., Kelly A. Plummer, Ph.D., Maarika L. Kimbrell, Maria E. Doukas, and Margaret C. Harney.