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Janssen Files BPCIA Litigation Against Alvotech’s Proposed Simponi® / Simponi Aria® Biosimilar AVT05

by Robert S. Schwartz, Ph.D.
June 23, 2026

On June 19, 2026, Janssen filed a BPCIA litigation, Case No. 1:26-cv-01754 (E.D. Va.) against Alvotech, alleging infringement of 14 of Janssen’s manufacturing patents by proposed Simponi® / Simponi Aria® (golimumab) biosimilar AVT05.  Alvotech resubmitted its aBLA for AVT05 earlier in June after receiving a Complete Response Letter from the FDA in November 2025 (previously reported aBLA Resubmissions: Xbrane’s Xlucane (ranibizumab) and Alvotech’s AVT05 (golimumab) and AVT06 (aflibercept); FDA Issues Complete Response Letter for Alvotech’s Simponi® (golimumab) Biosimilar AVT05).

This is the second BPCIA litigation related to a Simponi® / Simponi Aria® biosimilar, following Case No. 1:26-cv-00222 (D. Del.) filed in March 2026 against Accord and Bio-Thera’s Immgolis™ / Immgolis Intri™ (golimumab-sldi) (previously reported Janssen Files First BPCIA Suit Over Simponi® (golimumab) Biosimilar).  The Complaint against Alvotech asserts four patents against AVT05 that have not previously been asserted in litigation.

Simponi® / Simponi Aria® patents are also facing IPRs filed by Accord and Bio-Thera that are awaiting institution decisions: IPR2026-00256, -00257, -00258, and -00259 (previously reported Accord and Bio-Thera File Four IPRs Challenging Janssen Simponi® Patents).

Johnson & Johnson reported U.S. sales of $1.2B for Simponi® / Simponi Aria® in 2025.

For more information about these and other biosimilar patent disputes, 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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