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Approved Biosimilar Products

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 […]

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Summary of Amgen’s Opening and Responsive Brief in Sandoz v. Amgen

Amgen v. Sandoz (filgrastim)  •  Approved Biosimilar Products  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  Patent Dance  •  U.S. Biosimilar Litigation News  •  U.S. Federal Circuit Decisions
On Friday, March 10, Amgen filed its consolidated opening and responsive brief to the Supreme Court in Sandoz v. Amgen.  As we covered in a previous post, Sandoz filed its opening brief in the case last […]

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Janssen v. Celltrion: Trial Postponed, Briefing and Hearings Scheduled on Standing, Damages Issues

Approved Biosimilar Products  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  Janssen v. Celltrion (infliximab)  •  U.S. Biosimilar Litigation News
As we previously reported, a jury trial in the ongoing infliximab biosimilar litigation, Janssen v. Celltrion (D. Mass., J. Wolf), was scheduled to begin on February 13, 2017.  The district court, however, recently […]

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BREAKING NEWS: Supreme Court Grants Petition and Cross-Petition for Certiorari in Amgen v. Sandoz

Amgen v. Sandoz (filgrastim)  •  Approved Biosimilar Products  •  Biosimilar News  •  BPCIA and Related U.S. Statutes
The Supreme Court has granted Sandoz’s petition for certiorari, and Amgen’s cross-petition for certiorari in Amgen v. Sandoz.   The Order is excerpted below and can be found here: 15-1039  SANDOZ INC. V. AMGEN […]

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Janssen v. Celltrion: Court Denies Celltrion’s Summary Judgment Motion, Orders Further Briefing as to Hospira

Approved Biosimilar Products  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  Janssen v. Celltrion (infliximab)  •  U.S. Biosimilar Litigation News
This morning, in the district court action in Janssen v. Celltrion, Judge Wolf issued an oral order denying the defendants’ motion for partial summary judgment of non-infringement of U.S. Patent No. 7,598,083 (“the ’083 patent”) […]

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Coherus Announces Marketing Authorization Application to the EMA for Pegfilgrastim Biosimilar

Approved Biosimilar Products  •  Biosimilar News  •  EMA News
Coherus BioSciences, Inc., a global biosimilar company, is currently advancing three late-stage clinical products towards commercialization, namely CHS-1701 (pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and CHS-1420 (adalimumab biosimilar). In October, we reported that the FDA […]

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