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Patent Infringement AbbVie BPCIA

Venable LLP

Spotlight On: Biosimilar Litigations - August 2025

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Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

Goodwin

AbbVie Files Second Suit Against Alvotech For Patent Infringement Under the BPCIA

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On May 28, AbbVie brought a second action in the Northern District of Illinois for patent infringement against Alvotech hf. under the BPCIA in connection with Alvotech’s proposed biosimilar version of HUMIRA® (adalimumab)....more

Goodwin

FDA Approves Boehringer Ingelheim’s Adalimumab Biosimilar

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Today, Boehringer Ingelheim received FDA approval for Cyltezo®, its biosimilar to AbbVie’s Humira® (adalimumab). Cyltezo® is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic...more

Patterson Belknap Webb & Tyler LLP

New Biosimilar Litigation Reflects Benefits of Complying with BPCIA

On August 2, AbbVie sued Boehringer in the District of Delaware, alleging infringement of multiple patents related to AbbVie’s blockbuster biologic Humira (adalimumab). Though AbbVie has “more than 100 issued United States...more

Goodwin

Amgen Seeks Discovery Regarding AbbVie’s Patent Dance with Other Biosimilar Applicants

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In the ongoing litigation between AbbVie and Amgen regarding Amgen’s proposed biosimilar for Humira® (adalimumab), Amgen is seeking discovery from AbbVie regarding its exchanges with other adalimumab biosimilar applicants...more

Fish & Richardson

New Developments in AbbVie’s BPCIA Suit Targeting Amgen’s Humira® Biosimilar

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On August 4, 2016, AbbVie filed a complaint against Amgen alleging that Amgen’s Humira® biosimilar Amjevita® infringes ten AbbVie patents. Humira® received FDA approval in 2002 to treat rheumatoid arthritis, juvenile...more

Patterson Belknap Webb & Tyler LLP

Biosimilar Litigation Update

With the U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA) now fully up and running, there are now seven ongoing biosimilar litigations in the U.S. Here are brief updates on recent...more

Patterson Belknap Webb & Tyler LLP

Humira Biosimilar Approved As Litigation Gets Going

The FDA on Friday approved the first U.S. biosimilar of Humira (adalimumab), AbbVie’s best-selling biologic for treatment of inflammatory conditions. The biosimilar, Amgen’s Amjevita (adalimumab-atto), received approval for...more

Foley & Lardner LLP

AbbVie Sues Amgen On 10 Of 100 Humira Patents

Foley & Lardner LLP on

On August 4, 2016, Abbvie Inc. filed a complaint against Amgen, Inc. under the Biologics Price Competition and Innovation Act (BPCIA), asserting that Amgen’s application for approval of a biosimilar version of HUMIRA®...more

McDonnell Boehnen Hulbert & Berghoff LLP

AbbVie v. Amgen: The Litigation Phase for a HUMIRA® Biosimilar Begins

To date, Amgen has been the reference product sponsor for many biosimilar applications. Correspondingly, Amgen has been the Plaintiff in many of the litigations that have been based on the provisions of the Biosimilar Price...more

Goodwin

AbbVie Sues Amgen to Prevent Launch of Humira Biosimilar

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As we reported last week, on Thursday, August 4, AbbVie sued Amgen seeking an injunction to prevent Amgen from launching its biosimilar version of AbbVie’s Humira. The complaint alleges that Amgen’s biosimilar infringes 61...more

Goodwin

Breaking News: AbbVie Files Complaint Against Amgen

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AbbVie has filed a complaint against Amgen related to AbbVie’s Humira (adalimumab). The complaint asserts patent infringement and also seeks a declaratory judgment to compel Amgen to comply with the BPCIA’s notice of...more

Womble Bond Dickinson

Courts Answer Key Questions Over the Reach of the BPCIA

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Since the Biologics Price Competition and Innovation Act of 2009 (BPCIA) was signed into law in 2010, only a small handful of abbreviated Biologics Licensing Applications (“aBLAs”) have been filed and of those the FDA has...more

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