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