Blockbuster Biologics Review | Issue 23
May 2024Welcome 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 Q2 2024. 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 34%.
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FDA—Biosimilar Approvals
This section tracks all US biosimilar approvals. The number of approved US biosimilars is 51, with the most recent approval of Hercessi™ (trastuzumab-strf), Selarsdi™ (ustekinumab-aekn), Tyenne® (tocilizumab-aazg), Jubbonti® and Wyost® (denosumab-bbdz), and Simlandi® (adalimumab-ryvk).
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Legislative and Regulatory Updates
In this section, we highlight the reintroduced bill Increasing Access to Biosimilars Act that aims to boost competition and increase incentives for medical providers to prescribe biosimilars over their more expensive reference agents and the FDA’s new published draft guidance on promotional labeling and advertising considerations for biological reference products, biosimilar products, and interchangeable biosimilar products.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, Margaret C. Harney, and Jennifer Patritti-Cram, Ph.D.