Tagged as: Adalimumab

Abbvie and Adalimumab Biosimilar Manufacturers Face Class-Action Lawsuit Alleging Antitrust Violations Related to Patent Protection of Humira®

On March 18, 2019, UFCW Local 1500 Welfare Fund, a New-York based grocery union, filed a putative class-action lawsuit against AbbVie and seven adalimumab biosimilar manufacturers alleging misconduct and antitrust violations in connection with AbbVie’s assertion of patents to prevent the sale of biosimilar versions of Humira® in the United States….

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Coherus Settles with AbbVie, and Sues Amgen, Over Adalimumab Biosimilars (Updated)

Coherus announced today that it has executed settlement agreements with AbbVie that grant Coherus global, non-exclusive, royalty-bearing license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’ proposed adalimumab biosimilar.  According to the press release, the “global settlements resolve all pending disputes between the parties related to Coherus’ adalimumab biosimilar,” with Coherus’s…

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Court Grants BI Motion to Compel Discovery in Adalimumab Litigation (Updated)

On Monday, Magistrate Judge Lloret, who is visiting the U.S. District Court for the District of Delaware from the Eastern District of Pennsylvania, granted Boehringer Ingelheims’s (“BI’s”)  motion to compel discovery relating to its unclean hands defense in the ongoing AbbVie v. Boehringer Ingelheim litigation concerning BI’s aBLA for a biosimilar version of AbbVie’s…

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AbbVie and Pfizer Settle Adalimumab Biosimilar Patent Disputes

Today, AbbVie and Pfizer announced that they reached a global resolution of all intellectual property-related litigation concerning Pfizer’s proposed biosimilar adalimumab.  According to the press releases, AbbVie has granted Pfizer a non-exclusive license to AbbVie’s intellectual property relating to adalimumab in the United States and other countries.  All litigation pending between the parties…

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Amgen, Sandoz, Samsung, and Mylan Launch Biosimilars in Europe (UPDATED)

Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October.  On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched in European markets.  This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second biosimilar to launch in Europe overall.  According to…

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Sandoz Obtains FDA Approval for Adalimumab Biosimilar

The FDA announced today that it has approved Sandoz’s biosimilar Hyrimoz (adalimumab-adaz). The FDA had previously approved adalimumab biosimilars from Amgen and Boehringer Ingelheim. Sandoz’s global settlement with AbbVie regarding Hyrimoz provides Sandoz with a U.S. entry date of September 30, 2023, whereas Amgen is permitted an earlier U.S. launch,…

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AbbVie and Fresenius Kabi Settle Adalimumab Biosimilar Patent Disputes

Abbvie and Fresenius Kabi have announced today that they entered into a worldwide settlement and licensing arrangement resolving all intellectual property-related litigation concerning Fresenius’s MSB11022, a biosimilar candidate of AbbVie’s HUMIRA (adalimumab). According to the press releases, under the terms of the royalty-bearing settlement and license agreements, AbbVie has granted…

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