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FDA Issues Complete Response Letter for Alvotech’s Simponi® (golimumab) Biosimilar AVT05


November 6, 2025

On November 2, 2025, the FDA issued a complete response letter (CRL) for Alvotech’s abbreviated Biologics License Application (aBLA) for its proposed Simponi® (golimumab) biosimilar AVT05.

The CRL stated that certain deficiencies were identified after the FDA’s pre-license inspection of Alvotech’s Reykjavik manufacturing facility and must be adequately addressed before Alvotech’s aBLA can be approved. No additional issues were noted with the application. The facility remains FDA-approved for manufacturing and continues to supply currently commercialized products.

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 biosimilar patent disputes, please visit BiologicsHQ.

 

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The authors 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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