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Preliminary Injunction Against Accord’s Simponi® / Simponi Aria® Interchangeable Biosimilars Immgolis™ / Immgolis Intri™

by Robert S. Schwartz, Ph.D.
October 1, 2026

On September 30, 2026, in Case No. 1:26-cv-00222 (D. Del.), in a sealed opinion, the Court granted Janssen’s motion for a preliminary injunction against the commercial launch of Accord and Bio-Thera’s Simponi® / Simponi Aria® (golimumab) interchangeable biosimilars Immgolis™ / Immgolis Intri™ (golimumab-sldi).  According to the Order, Janssen is to post a bond of $98.8 million.  Janssen’s motion for a temporary restraining order was denied as moot.  On October 5, 2026, Accord and Bio-Thera filed CAFC Appeal No. 27-1008, appealing the grant of the preliminary injunction.

Accord and Bio-Thera are also involved in four IPRs challenging Janssen’s Simponi® / Simponi Aria® patents that were instituted earlier in September (previously reported PTAB Director Institutes Four Simponi® / Simponi Aria® (golimumab) IPRs).

Alvotech and Teva have a pending aBLA for a Simponi® / Simponi Aria® biosimilar, AVT05, that was resubmitted in June 2026.  A motion for a preliminary injunction has been filed in Case No. 1:26-cv-01754 (E.D. Va.) (previously reported Janssen Files BPCIA Litigation Against Alvotech’s Proposed Simponi® / Simponi Aria® Biosimilar AVT05).

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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