Spotlight On: Biosimilar Litigations

Spotlight On: Biosimilar Litigations

by | Aug 31, 2026

                              Download PDF Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products.  Litigations between...
Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) / Hadlima™ (adalimumab-bwwd) / Abrilada™ (adalimumab-afzb) / Hulio® (adalimumab-fkjp) / Yusimry™ (adalimumab-aqvh) / Idacio® (adalimumab-aacf) / Yuflyma® (adalimumab-aaty) / Simlandi® (adalimumab-ryvk)

Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) / Hadlima™ (adalimumab-bwwd) / Abrilada™ (adalimumab-afzb) / Hulio® (adalimumab-fkjp) / Yusimry™ (adalimumab-aqvh) / Idacio® (adalimumab-aacf) / Yuflyma® (adalimumab-aaty) / Simlandi® (adalimumab-ryvk)

by | Aug 31, 2026

        Download PDF *Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs.  Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...

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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