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. 

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