Blockbuster Biologics Review | Issue 15
April 2022Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges inter partes reviews (IPRs) and post-grant reviews (PGRs), patent litigations implicating blockbuster biologics, and legislative proposals related to biosimilars in Q1 2022. We will continue to monitor developments in these post-grant challenges and litigations and provide you with regular updates.
Inter Partes Reviews (IPRs) and Litigations
In this section, we break down IPRs and Biologics Price Competition and Innovation Act (BPCIA) litigations filed in the biologics space, covering the types of claims being challenged, the number filed each year, and their outcome. Notably, the current institution rate for IPR challenges to patents that claim biologics—excluding IPRs that have settled or otherwise been terminated—stands at 38%.
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FDA—Biosimilar Approvals
This section tracks all US biosimilar approvals. The number of approved US biosimilars is 34, with the most recent approval occurring in Q1 2022.
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Legislative and Regulatory Updates
In this section we highlight the legislative and FDA updates in the United States, touching on biosimilars,—including an FDA program to fund several research proposals under the regulatory science pilot for biosimilars—under the Biosimilar User Fee Amendments (BsUFA III) program to advance the development of interchangeable products and make biosimilar development more efficient.
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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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