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FDA Rejects Hospira’s Epogen Biosimilar
Last year, Hospira, Inc. (owned by Pfizer, Inc.) submitted an abbreviated Biologics License Application (aBLA) for its proposed biosimilar to Amgen’s Epogen (epoetin alfa). The biosimilar has been...
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Amgen v. Hospira: Amgen Appeals Discovery Ruling
In the Amgen v. Hospira litigation, Amgen has filed a Notice of Appeal relating to Judge Andrew’s oral ruling denying Amgen’s request to compel Hospira to produce certain manufacturing information...
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Biosimilar Updates: Epoetin, Rituximab, Adalimumab
Over the past week or so, several biologic and biosimilar companies have issued their year-end earnings reports. Below are some highlights on the biosimilar front: Pfizer recently reported in a press...
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Amgen Seeks Preliminary Injunction Against Hospira’s Launch of Epoetin Alfa...
On Friday, in the ongoing Amgen v. Hospira district court litigation regarding Hospira’s proposed biosimilar of Epogen®/Procrit® (epoetin alfa), Amgen filed a motion for preliminary injunction seeking...
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Sandoz Pushes Back Pegfilgrastim U.S. Resubmission Target Date
Novartis recently released its Q2 2017 financials, which included updates on various biosimilar products in its subsidiary Sandoz’s pipeline. Pegfligrastim As we previously reported last July, the FDA...
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Hospira Files Motion for JMOL, Challenging Jury’s $70M Damages Award
As we recently reported, a federal jury awarded Amgen $70 million in damages last week after finding that Hospira’s manufacture of 14 batches of drug substance between 2013 and 2015 was not protected...
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Hospira Appeals $80 Million Judgment in Epoetin Alfa Biosimilar Case
As we reported, last month in the Amgen v. Hospira litigation concerning Hospira’s Retacrit (epoetin alfa) biosimilar, the Delaware district court entered final judgment against Hospira, awarding Amgen...
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Federal Circuit Round Up: Epoetin Alfa, Adalimumab, Rituximab
April has seen a flurry of biosimilar-related appellate activity before the Federal Circuit. Below are some highlights. The parties in the Amgen v. Hospira BPCIA litigation concerning Hospira’s...
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Hospira Asks Federal Circuit to Take Fresh Look at Safe Harbor Ruling in...
Last month, a three-judge panel of the Federal Circuit affirmed a Delaware district court’s judgment of infringement against Hospira and $70 million damages award to Amgen in the parties’ BPCIA...
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White Paper Investigates Biosimilar Competition and Price Reduction
In March 2021, researchers from Harvard Medical School, Harvard University, and Brigham and Women’s Hospital published a white paper exploring the link between entry of biosimilars under The Biological...
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