According to a January 2024 press release from Accord BioPharma, Inc. (“Accord”), the FDA accepted Accord’s abbreviated Biologics License Application (aBLA) for DMB-3115 (ustekinumab), a proposed biosimilar to Janssen Biotech’s (a Johnson & Johnson company) Stelara® (ustekinumab).  According to Accord’s press release, Accord also publicly disclosed for the first time that it previously submitted aBLAs for a filgrastim (Neupogen®) biosimilar and a pegfilgrastim (Neulasta®) biosimilar.

In 2013, Dong-A Socio Holdings and Meiji Seika Pharma began joint development for DMB-3115, with exclusive rights granted to Intas Pharmaceuticals after a partnership was announced in 2021. Accord, a subsidiary of Intas Pharmaceuticals, will be responsible for commercialization of DMB-3115 in the United States.

This is the fifth pending aBLA for a proposed biosimilar of Stelara®. According to Accord’s press release, it reached a settlement with Janssen in October 2023, prior to any biosimilar patent disputes in the United States, that would allow it to launch DMB-3115 in the United States no later than May 15, 2025, pending its approval by the FDA.

J&J reported that Stelara® had U.S. sales of about $6.97B in 2023.  We continue to monitor this aBLA.  For more information on pending aBLAs and biosimilar-related patent disputes, please visit



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


    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( 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 ( 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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