On January 27, 2025, Alvotech and Teva announced the FDA acceptance of an aBLA for AVT05, a proposed biosimilar of Janssen’s Simponi® / Simponi Aria® (golimumab). This is the first publicly announced acceptance of an aBLA of a golimumab biosimilar. According to a press release, the FDA review process is anticipated to be completed in the fourth quarter of 2025. Currently, there are no pending U.S. patent disputes related to Simponi® / Simponi Aria® biosimilars.
Johnson & Johnson reported U.S. sales of $1.12B for Simponi® / Simponi Aria® in 2023.
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The author would like to thank April Breyer Menon for her contributions to this article.
