Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
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
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
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
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
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
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
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