Blockbuster Biologics Review | Issue 22
February 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 Q1 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 45, with the most recent approval of Avzivi® (bevacizumab-tnjn) and Wezlana™ (ustekinumab-auub).
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Legislative and Regulatory Updates
In this section, we highlight the National Institute of Standards and Technology’s (NIST’s) draft guidance for the exercise of march-in rights under the Bayh-Dole Act and the FDA’s new Advanced Manufacturing Technologies (AMT) Designation Program and Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program.
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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.