Blockbuster Biologics Review | Issue 28
August 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 Q3 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 76, with the most recent approvals being Kirsty™ (insulin aspart-xjhz) and Starjemza® (ustekinumab-hmny).
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Legislative and Regulatory Updates
In this section, we highlight the reintroduction of the Biosimilar Red Tape Elimination Act and the introduction of the Eliminating Thickets to Improve Competition (ETHIC) Act. On the regulatory front, the FDA announced FY2026 biosimilar user fees and finalized guidance for “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.”
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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.