Report
Blockbuster Biologics Review | Issue 13
August 2021Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges (IPRs and PGRs) and patent litigations implicating blockbuster biologics in 2Q 2021. 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 BPCIA litigations filed in the biologics space, including 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 37%.
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FDA: Biosimilar Approvals
This section tracks all US biosimilar approvals. The number of approved US biosimilars remains at 29, with no new approvals in Q2 2021.
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Legislative Updates
In this section, we highlight the legislative updates in the United States touching on biosimilars, including a bill introduced in the House designed to decrease biosimilar drug costs by increasing reimbursement to hospitals and doctors. Additionally, the Biden-Harris administration issued a series of executive orders on July 16, 2021 charging the Department of Health and Human Services to promote generic drug and biosimilar competition.
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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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