Blockbuster Biologics Review | Issue 25

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 Q4 2024. We will continue to monitor developments in these post-grant challenges and litigations and provide you with regular updates.

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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 57%.
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FDA—Biosimilar Approvals
This section tracks all US biosimilar approvals. The number of approved US biosimilars is 62, with the most recent approvals being Otulfi® (ustekinumab-aauz), Imuldosa® (ustekinumab-srlf), and Pavblu® (aflibercept-ayyh).
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Legislative and Regulatory Updates
In this section, we highlight the recently passed Affordable Prescriptions for Patients Act, which limits the number of certain types of patents that can be asserted during BPCIA litigation, and a companion bill awaiting action by the House of Representatives.
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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, Margaret C. Harney, and Jennifer Patritti-Cram, Ph.D.