Blockbuster Biologics Review | Issue 16
July 2022Welcome 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 2022. 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 37%.
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FDA—Biosimilar Approvals
This section tracks all US biosimilar approvals. The number of approved US biosimilars is 36, with the most recent approval occurring in Q2 2022.
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Legislative and Regulatory Updates
In this section, we highlight the legislative and US Food and Drug Administration (FDA) updates, touching on biosimilars—including the Senate’s Committee on Health, Education, Labor and Pensions (HELP) latest version of its FDA user fee reauthorization bill, which would allow for tentative interchangeable approvals and shared first interchangeable exclusivity for multiple first filers.
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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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