Archives for 

Approved Biosimilar Products

Amgen and AbbVie Settle Adalimumab BPCIA Litigation

AbbVie v. Amgen (adalimumab)  •  AbbVie v. Boehringer Ingelheim (adalimumab)  •  Approved Biosimilar Products  •  Biologics Litigation  •  Biosimilar News  •  U.S. Biosimilar Litigation News
Amgen has announced that it has settled all pending patent litigation regarding AMJEVITA, its biosimilar version of AbbVie’s Humira® (adalimumab). Amgen reports that AbbVie will grant patent licenses for the use and sale […]

View More

Amgen v. Sandoz: Federal Circuit Vacates Opinion and Mandate, Reinstates Appeal, Orders Further Briefing on Remanded Issues

Amgen v. Sandoz (filgrastim)  •  Approved Biosimilar Products  •  Biologics Litigation  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  U.S. Biosimilar Litigation News  •  U.S. Federal Circuit Decisions  •  U.S. Supreme Court Decisions
As we previously reported, following the Supreme Court’s decision in Sandoz v. Amgen, Sandoz requested a remand to the District Court to answer the two questions that the […]

View More

FDA Advisory Committee Recommends Approval of Pfizer’s EPOGEN®/PROCRIT® Biosimilar

Amgen v. Hospira (epoetin alfa)  •  Approved Biosimilar Products  •  Biosimilar News
As we previously reported, the FDA Oncologic Drugs Advisory Committee (“ODAC”) held a public meeting today regarding Hospira’s application for its proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa).  Pfizer, Hospira’s parent company, has announced today […]

View More

Supreme Court Oral Argument in Sandoz v. Amgen

Amgen v. Sandoz (filgrastim)  •  Approved Biosimilar Products  •  Biologics Litigation  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  Patent Dance  •  U.S. Biosimilar Litigation News  •  U.S. Federal Circuit Decisions
The Supreme Court held a 70-minute oral argument in Sandoz v. Amgen this morning. Before beginning the argument, the Chief Justice announced that the Court would give each side five extra minutes–a highly unusual step reflecting […]

View More