Tagged as: Inflectra

Year in Review: Top Legal Developments of 2023

As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market.  The following is a recap of some of the top five legal decisions and developments in the biosimilars and biologics space in 2023 that we covered…

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Celltrion USA Announces Submission of BLA for Subcutaneous Infliximab Biosimilar 

On December 22, 2022, Celltrion USA announced that it submitted a Biologics License Application (BLA) for a subcutaneous formulation of infliximab, CT-P13, to the U.S. Food and Drug Administration (FDA).  According to Celltrion, the BLA is based on phase III pivotal data that evaluated the efficacy and safety of CT-P13 as a…

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Positive Results From Ustekinumab Biosimilar Phase I Trial and Infliximab Biosimilar Switching Studies

On October 20, 2020, NeuClone announced that it successfully completed its Phase I clinical trial of NeuLara, its proposed biosimilar of Stelara (ustekinumab).  According to Neuclone, the Phase I clinical trial demonstrated similar clinical pharmacokinetics, and safety, immunogenicity and tolerability profiles of NeuLara compared to US- and EU-sourced Stelara.  NeuLara…

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Janssen Appeals District Court’s Summary Judgment of Non-Infringement in INFLECTRA Litigation (UPDATED)

As we have previously covered, last month the court in Janssen v. Celltrion (D. Mass., J. Wolf) issued a memorandum opinion granting Celltrion’s motion for summary judgment of non-infringement of the sole remaining patent-in-suit, and the next day entered final judgment for Celltrion. The court subsequently entered an amended final judgment to dismiss without prejudice Celltrion’s…

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Judge Sets Trial Date in Janssen v. Celltrion Should Summary Judgment Be Denied

As we reported here, in the patent dispute between Janssen and Defendants Celltrion and Hospira relating to Inflectra® (infliximab-dyyb), a biosimilar of Remicade®, there are multiple motions for summary judgment pending before Judge Wolf in the District of Massachusetts. Both parties have filed competing summary judgment motions directed to damages issues. Additionally, Defendants have filed a motion…

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Janssen v. Celltrion: Motions to Exclude or Limit Evidence and Testimony from the Upcoming Trial

With the pre-trial conference set to begin on February 6, 2017, the parties in Janssen v. Celltrion have filed several motions seeking to exclude or limit certain evidence and testimony that may be offered at trial. Expert Testimony Celltrion has filed a motion to exclude the opinions of Janssen’s proffered expert…

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Janssen v. Celltrion: Janssen Appeals Judgment Invalidating the ’471 Patent

As we previously reported, on September 26, 2016, the district court in Janssen v. Celltrion entered partial final judgment that the ’471 patent, asserted by Janssen, was invalid.  Today, Janssen filed a notice that they are appealing the district court’s judgment to the Federal Circuit. Meanwhile, Celltrion’s partner Pfizer announced last week that it will begin shipping…

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