Tagged as: Amgen

Another Biosimilar Litigation Settlement: Amgen v. Tanvex (Filgrastim)

Following last month’s dismissal of the Amgen v. Kashiv filgrastim biosimilar litigation, yesterday Amgen and Tanvex filed a joint stipulation of dismissal in their BPCIA litigation concerning Tanvex’s filgrastim biosimilar candidate. The stipulation states that the parties agree “to the dismissal, without prejudice, of all remaining claims and counterclaims in…

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BREAKING NEWS: Federal Circuit Affirms Amgen’s $70 Million Damages Award Against Pfizer Unit

This morning, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit issued a 24-page opinion affirming the district court’s judgment in favor of Amgen in its four-year long BPCIA patent ligation against Hospira, a subsidiary of Pfizer, regarding a biosimilar of Amgen’s EPOGEN (epoetin alfa). On…

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Coherus and Amgen Stipulate to Dismissal of Adalimumab Infringement Case

As we previously reported, earlier this year Coherus filed a complaint against Amgen in the District of Delaware alleging infringement of patents claiming “stable aqueous pharmaceutical compositions” comprising adalimumab and other components.  Coherus alleged that “Amgen is actively offering for sale and selling Amgevita™ [Amgen’s tradename for its adalimumab biosimilar…

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Amgen and Kashiv Ask District Court to Dismiss Their Filgrastim Biosimilar Litigation

On November 22, 2019, the parties in the Amgen v. Kashiv BPCIA litigation, concerning Kashiv’s proposed biosimilar of NEUPOGEN (filgrastim), submitted a stipulation of dismissal indicating that they have “agree[d] to the dismissal, without prejudice, of all remaining claims and counterclaims in this action with the parties to bear their own…

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Amneal, Amgen, and Kashiv jointly stipulate to dismiss patent in filgrastim litigation

As we previously reported, Amgen filed a complaint against Adello Biologics and Amneal alleging infringement of several patents, including certain claims of U.S. Patent No. 8,952,138, directed to a protein refolding process. In their answer, Adello sought a declaratory judgment that certain claims of the ’138 patent were not infringed…

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Accord BioPharma substituted for Apotex as party in filgrastim/pegfilgrastim biosimilar litigation

As we previously reported, the parties in the follow-on Amgen v. Apotex BPCIA litigation concerning Apotex’s proposed biosimilars of NEUPOGEN (filgrastim) and NEULASTA (pegfilgrastim) informed the district court on August 8 that they were drafting a stipulation and unopposed motion that would substitute Apotex as a party with a then-unnamed…

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Amgen and Allergan Announce Positive Results from Clinical Study of Rituxan Biosimilar Candidate

On August 22, Amgen and Allergan announced positive top-line results from a clinical study (JASMINE) comparing the efficacy and safety of the biosimilar candidate ABP 798 (rituximab) to the reference drug Rituxan® in patients with CD20-positive B-cell non-Hodgkins lymphoma. As we reported in January, ABP 798 was previously found to…

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