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Genentech and Biocon Settle Perjeta® BPCIA Litigation

by Robert S. Schwartz, Ph.D.
October 16, 2026

On October 14, 2026, Genentech voluntarily dismissed BPCIA litigation No. 2:26-cv-09585 (D.N.J.) against Biocon related to its proposed Perjeta® (pertuzumab) biosimilar Pebrilzo™ (Bmab 1500) (previously reported Genentech Files BPCIA Litigation Against Biocon’s Proposed Perjeta® Biosimilar Bmab 1500) due to a global settlement agreement.  Under the settlement, Biocon can launch its biosimilar in the third quarter of 2028 (or earlier in certain undisclosed circumstances), subject to FDA approval.  It secured earlier launch dates of the first quarter of 2027 in the E.U. and U.K., and during 2026-2028 in the rest of the world.

Genentech previously withdrew its ITC complaint against Biocon in Case No. ITC-337-3890 in June 2026 based on representations from Biocon that the imported product was solely for uses related to FDA approval and covered by the § 271(e)(1) safe harbor (previously reported Genentech Files ITC Complaint Targeting Biocon’s Proposed Perjeta® (pertuzumab) Biosimilar; Genentech Files BPCIA Litigation Against Biocon’s Proposed Perjeta® Biosimilar Bmab 1500).

Biocon filed its aBLA for Pebrilzo™ on an undisclosed date prior to January 2026.

In January 2026, Genentech and Shanghai Henlius Biotech settled BPCIA litigation No. 2:25-cv-14648 (D.N.J.) related to Henlius’s interchangeable biosimilar Poherdy® (pertuzumab-dpzb), (previously reported Genentech and Shanghai Henlius Biotech Settle Perjeta® Biosimilar BPCIA Litigation) which was approved in November 2025 (previously reported FDA Approves First Perjeta® Biosimilar: Shanghai Henlius Biotech / Organon’s Poherdy®).

There are no other ongoing patent disputes related to Perjeta® biosimilars.

Roche reported U.S. sales of approximately $1.62B USD (1.27B CHF) for Perjeta® in 2025.

For more information about these and other biosimilars, please visit BiologicsHQ.

 

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The author would like to thank April Breyer Menon for her contributions to this article.

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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