Blockbuster Biologics Review | Issue 24
August 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 Q3 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 57%.
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FDA—Biosimilar Approvals
This section tracks all US biosimilar approvals. The number of approved US biosimilars is 59, with the most recent approval of Enzeevu™ (aflibercept-abzv), Epysqli® (eculizumab-aagh), Ahzantive® (aflibercept-mrbb), Nypozi™ (filgrastim-txid), Pyzchiva® (ustekinumab-ttwe), Bkemv™ (eculizumab-aeeb), Yesafili® (aflibercept-jbvf), and Opuviz™ (aflibercept-yszy).
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Legislative and Regulatory Updates
In this section, we highlight the US Food and Drug Administration’s recently published draft guidance announcing that it intends to revise its May 2019 guidance on Considerations in Demonstrating Interchangeability With a Reference Product (Interchangeability Guidance) to reflect their current thinking regarding switching studies.
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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.