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News

Alvotech and Teva Announce First FDA Acceptance of aBLA for Simponi® / Simponi Aria® (golimumab) Biosimilar

by Robert S. Schwartz, Ph.D.
January 29, 2025

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.

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.

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    Pharma Biosimilar Biologic Drug Medicine TN

    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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