Tagged as: Biosimilars News

BREAKING NEWS: Jury’s $70M Award Against Hospira for Infringing Amgen's Epoetin Patent Survives Post-Trial Motions

As we previously reported, last September a District of Delaware jury issued a verdict that Hospira’s manufacture of 14 batches of drug substance in connection with its proposed biosimilar of Amgen’s Epogen® (epoetin alfa) was not protected activity under the § 271(e)(1) safe harbor and infringed Amgen’s ’298 patent, and…

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Bio-Thera Solutions Provides Regulatory and Clinical Development Updates for Proposed Biosimilars

Guangzhou-based biopharmaceutical company Bio-Thera Solutions recently announced that the China National Drug Administration has accepted for review the BLA for BAT1406, a proposed Humira® (adalimumab) biosimilar.  Bio-Thera states that the BAT1406 BLA contains clinical data from a pharmacokinetic/pharmacodynamic (PK/PD) trial and a Phase III confirmatory safety and efficacy study in…

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Breaking News Update – Janssen v. Celltrion: District Court Rules in Favor of Celltrion on Summary Judgment of Non-Infringement

Today, Judge Wolf found in favor of Celltrion, granting its motion for summary judgment of non-infringement of the sole remaining patent-in-suit based on an application of the ensnarement doctrine to Janssen’s infringement theory under the doctrine of equivalents.  The Court determined that Celltrion’s infliximab biosimilar does not infringe Janssen’s ’083…

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