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Bio-Thera Submits aBLA for Simponi® (golimumab) Biosimilar BAT2506


July 24, 2025

On July 16, 2025, Bio-Thera Solutions and Accord announced the FDA acceptance of their aBLA for BAT2506, a proposed biosimilar of Janssen / Johnson & Johnson’s Simponi® (golimumab).  Under a license and commercialization agreement, Bio-Thera is responsible for the development and manufacturing of BAT2506, and Accord will be responsible for marketing if it is approved in the U.S.  The FDA goal date has been set for May 16, 2026.

In January, Alvotech and Teva announced submission of an aBLA for their proposed biosimilar AVT05 (golimumab) (previously reported Alvotech and Teva Announce First FDA Acceptance of aBLA for Simponi® / Simponi Aria® (golimumab) Biosimilar).

Currently, there are no pending U.S. patent disputes related to Simponi® / Simponi Aria® biosimilars.

Johnson & Johnson reported U.S. sales of $1.08B for Simponi® / Simponi Aria® in 2024.

For more information about these and other biosimilars, 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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