Blockbuster Biologics Review | Issue 26
February 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 Q1 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 57%.
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FDA—Biosimilar Approvals
This section tracks all US biosimilar approvals. The number of approved US biosimilars is 67, with the most recent approvals being Ospomyvtm® (denosumab-dssb), Xbryktm® (denosumab-dssb), Avtozma® (tocilizumab-anoh), Steqeyma® (Ustekinumab-stba), and Yesintek® (ustekinumab-kfce).
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Legislative and Regulatory Updates
In this section, we highlight the recently introduced bipartisan bill Skinny Labels, Big Savings Act, which aims to lower drug prices and provide protections from litigation for generic and biosimilar drug manufacturers who obtain “skinny label” FDA approvals. On the regulatory front, the FDA’s Center for Drug Evaluation and Research (CDER) has released its annual guidance agenda, outlining the guidance documents it intends to publish in 2025, including a planned guidance on exclusivity for first interchangeable biosimilar biological 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.