Blockbuster Biologics Review | Issue 29
December 2025Welcome 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 Q4 2025. We will continue to monitor developments in these post-grant challenges and litigations and provide you with regular updates.
Post-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 58%.
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FDA—Biosimilar Approvals
This section tracks all US biosimilar approvals. The number of approved US biosimilars is 78, with the most recent approvals being Poherdy® (pertuzumab-dpzb), Osvyrti® and Jubereq® (denosumab-desu), and Eydenzelt® (aflibercept-boav).
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Legislative and Regulatory Updates
In this section, we highlight the introduction of the Biosimilar Red Tape Elimination Act. On the regulatory front, the FDA issued draft guidance for “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.”
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Supporting Documents
This section provides a product-by-product breakdown of biologics-related patents that have been subject to an IPR, including the challenged claims.
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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.