Amgen

The Biosimilars Council Supports Sandoz’s Preemption Position in Federal Circuit Amicus Brief

September 15, 2017 Posted by Big Molecule Watch

Amgen v. Sandoz (filgrastim) • U.S. Biosimilar Litigation News

Last week the Biosimilars Council submitted an amicus brief in the Federal Circuit remand proceedings for Amgen v. Sandoz, arguing that Amgen’s state-law claims for Sandoz’s failure to comply with the patent dance’s disclosure […]

FDA Approves Amgen’s Biosimilar of Avastin® (UPDATED)

September 14, 2017 Posted by Big Molecule Watch

Today, the FDA announced that it has approved Mvasi® (bevacizumab-awwb), Amgen’s biosimilar of Genentech’s Avastin®. According to the announcement, Mvasi® is the first biosimilar that the FDA has approved for the treatment of cancer. Mvasi® […]

Amgen/Allergan and Pfizer Present Positive Phase 3 Data For Two Investigational Trastuzumab Biosimilars

September 13, 2017 Posted by Big Molecule Watch

Biosimilar News

At the European Society for Medical Oncology (“ESMO”) 2017 Congress, which was held over the past several days in Madrid, Spain, companies presented Phase 3 clinical data regarding two investigational biosimilars of Herceptin (trastuzumab). First, […]

U.S. Argues Amgen’s State Law Claim Preempted by BPCIA, Supporting Sandoz

September 12, 2017 Posted by Big Molecule Watch

Amgen v. Sandoz (filgrastim) • U.S. Biosimilar Litigation News

Yesterday, in the remanded appeal in Amgen v. Sandoz, the United States submitted an amicus brief to the Federal Circuit that generally supports the position taken by Sandoz and the Biosimilars Council […]

Amgen v. Hospira: Litigation Update

September 12, 2017 Posted by Big Molecule Watch

Amgen v. Hospira (epoetin alfa) • U.S. Biosimilar Litigation News

With the September 18, 2017 trial date fast approaching, the district court in Amgen v. Hospira last week denied Hospira’s motion for summary judgment of non-infringement of its proposed biosimilar of Epogen®/Procrit® (epoetin alfa) […]

Amgen v. Coherus: Coherus Files Reply in Support of Motion to Stay

August 16, 2017 Posted by Big Molecule Watch

Amgen v. Coherus (pegfilgrastim)

As we have previously reported, on July 25th, Coherus filed a motion to stay discovery pending the result of its motion to dismiss in its litigation against Amgen regarding pegfilgrastim, and Amgen filed […]

Q2 Earnings Round-Up

August 9, 2017 Posted by Big Molecule Watch

Biosimilar News • Deal Watch

Below are some highlights from second quarter earnings reports recently released by biologics and biosimilar companies. Coherus reported that it has cash and cash equivalents of $118.3 million as of June 30, 2017 and that […]

Celltrion/Teva and Amgen/Allergan Announce FDA Submissions for Proposed Biosimilars of Herceptin®

August 1, 2017 Posted by Big Molecule Watch

Biosimilar News

Yesterday, two groups announced the submission of applications seeking FDA approval of biosimilars of Herceptin® (trastuzumab), which is indicated for the treatment of HER2-positive early breast cancer, adjuvant breast cancer, metastatic breast cancer and metastatic gastric […]

Sanofi Files a Second Petition for IPR of Immunex’s Dupixent Patent

July 31, 2017 Posted by Big Molecule Watch

PTAB + IPR

Sanofi-Aventis has filed a petition for IPR of Immunex Corporation’s U.S. Patent 8,679,487, directed to isolated human antibodies that compete with a reference antibody for binding to human interleukin-4 (IL-4) receptor. The proceeding has been […]

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

July 27, 2017 Posted by Big Molecule Watch

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 […]