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Injunctive Relief Amgen

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

Williams Mullen

Biosimilar “Patent Dance” Does Not Permit Sidestepping of 180-Day Notice

Williams Mullen on

On July 5, 2016, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) unanimously ruled in Amgen v. Apotex that biosimilar makers must provide brand-name rivals with a 180-day notice only after receipt of...more

Goodwin

Amgen v. Sandoz: Sandoz’s Opposition to Amgen’s Conditional Cross-Petition for Certiorari

Goodwin on

As we covered in a previous post, following the Federal Circuit’s decision in Amgen v. Sandoz, Sandoz filed a petition for a writ of certiorari asking the Supreme Court to review the Federal Circuit’s interpretation of the...more

Foley & Lardner LLP

Amgen Hedges Its Bets With Cross-Petition For Certiorari Of Biosimilar Decision

Foley & Lardner LLP on

Although Amgen originally did not petition the Supreme Court for certiorari to review the first Federal Circuit decision interpreting the BPCIA framework for resolving biosimilar patent disputes, Amgen now has filed a...more

Foley & Lardner LLP

Sandoz Asks Supreme Court To Reverse Biosimilar Decision

Foley & Lardner LLP on

On February 16, 2016, Sandoz, Inc. filed a petition for writ of certiorari to the Supreme Court, asking the Court to overturn the Federal Circuit decision that interpreted the “patent dance” provisions of the Biologics Price...more

McDonnell Boehnen Hulbert & Berghoff LLP

Celltrion's Proposed REMICADE® Biosimilar Recommended for Approval

On February 10, 2016, the FDA's Arthritis Advisory Committee recommended approval of biologics license application ("BLA") 125544 submitted by Celltrion, Inc. for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s...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

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