News & Analysis as of

Counterclaims Biosimilars

Goodwin

AbbVie Inc. et al. v. Alvotech hf. Updates

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We have previously reported on AbbVie’s first and second wave suits against Alvotech hf. (Alvotech) in the Northern District of Illinois regarding an adalimumab biosimilar. In the second wave suit, on December 21, 2021,...more

Goodwin

Litigation Update: AbbVie v. Alvotech hf (Adalimumab)

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We have previously reported on AbbVie’s first and second wave suits against Alvotech hf (Alvotech) in the Northern District of Illinois regarding an adalimumab biosimilar. In the first wave suit, on October 5, 2021 AbbVie...more

Goodwin

Litigation Update: Genentech’s Motion to Dismiss Amgen’s Counterclaims Denied in Avastin Biosimilar Litigation

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On February 11, 2020, in the Biogen v. Amgen BPCIA litigation regarding MVASI (bevacizumab-awwb), Amgen’s biosimilar of AVASTIN, Judge Colm Connolly of the Delaware District Court denied most of Genentech’s motion to dismiss...more

Goodwin

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

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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...more

Goodwin

Biosimilar Litigation Updates

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Below is an update on recent developments in several litigations involving biosimilar products. Amgen v. Sandoz (filgrastim, pegfilgrastim): As we previously reported, the district court granted summary judgment of...more

Goodwin

Genentech Seeks to Dismiss and Strike Amgen’s Counterclaims and Certain Defenses in Bevacizumab Biosimilar Litigation

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As we previously reported, on May 22, 2018 in Genentech v. Amgen, which concerns Amgen’s Mvasi® (bevacizumab-awwb) biosimilar, Genentech filed a motion to dismiss and to strike Amgen’s counterclaims and certain affirmative...more

Goodwin

Litigation Update: Answer Filed in AbbVie v. Amgen

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Amgen has filed its answer in response to AbbVie’s complaint alleging infringement of 10 patents that allegedly cover Amgen’s recently-approved adalimumab biosimilar, Amjevita (formerly known as ABP501). Amgen asserts...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

Patterson Belknap Webb & Tyler LLP

Apotex Drops Sham Litigation Counterclaims in Neupogen and Neulasta Biosimilar Litigation

In a consolidated litigation in the Southern District of Florida involving Apotex’s proposed biosimilars of Amgen’s Neupogen, an anti-infection drug for cancer patients, and of Amgen’s Neulasta, a long-acting version of...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Patterson Belknap Webb & Tyler LLP

Apotex Accuses Amgen of Sham BPCIA Litigation

Amgen recently sued Apotex under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) over Apotex’s proposed biosimilar of Amgen’s Neulasta (pegfilgrastim), a long-lasting version of Neupogen. This is the first...more

Wilson Sonsini Goodrich & Rosati

Federal Circuit Amgen Case Clarifies Important Aspects of the Biologics Price Competition and Innovation Act

On July 21, 2015, the U.S. Court of Appeals for the Federal Circuit issued its holding in Amgen Inc. v. Sandoz Inc., 2015-1499 (Fed. Cir. 2015). The Federal Circuit's decision is the latest development in the long-running...more

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