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Janssen Files First BPCIA Suit Over Simponi® (golimumab) Biosimilar

by Robert S. Schwartz, Ph.D.; Leah Watson
March 6, 2026

On March 3, 2026, Janssen filed a Complaint in the U.S. District Court for the District of Delaware against Accord and Bio-Thera Solutions, Case No. 1:26-cv-00222 (D. Del.), initiating the first BPCIA litigation related to Janssen / Johnson & Johnson’s Simponi® (golimumab) biosimilar.

Accord and Bio-Thera are developing BAT2506 for which the FDA accepted an abbreviated Biologics License Application (aBLA) in July 2025 (previously reported Bio-Thera Submits aBLA for Simponi® (golimumab) Biosimilar BAT2506).

The Complaint is currently under seal. A Report to the Commissioner of Patents and Trademarks identifies 17 patents that are listed in the FDA’s Purple Book for Simponi®. The patents include 13 with manufacturing claims, 4 with method of treatment claims, 2 with composition claims, and 2 with composition of matter claims.

Another golimumab biosimilar aBLA from Alvotech and Teva for AVT05 (golimumab) was accepted by the FDA in January 2025 (previously reported Alvotech and Teva Announce First FDA Acceptance of aBLA for Simponi® / Simponi Aria® (golimumab) Biosimilar), and was issued a Complete Response Letter in November 2025 (previously reported FDA Issues Complete Response Letter for Alvotech’s Simponi® (golimumab) Biosimilar AVT05).

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

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

 

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The authors 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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