Tagged as: Infliximab

Year in Review: Top Regulatory Developments of 2023

As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023.  Below are some of the top regulatory developments from 2023. FDA Approvals In 2023, there were 23 FDA approvals of Biologic License Applications, including for Vertex’s CASGEVY and Bluebird’s LYFGENIA, the first…

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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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REMICADE Antitrust Settlement Receives Final Approval

In 2017, three indirect-purchaser antitrust class actions were filed against Johnson & Johnson and Janssen Biotech, Inc., alleging that they engaged in anticompetitive conduct relating to the sale and marketing of J&J’s REMICADE (infliximab).  The class actions were brought by employee welfare benefit plans, specifically the National Employees Health Plan,…

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Year in Review: Top Deals in 2022

According to PwC, “2022 has been a challenging year for M&A in the pharmaceutical and life sciences sector, with both deal value and volume at multiyear lows thanks to overall macro headwinds coupled with broad-based market dislocation.”  PwC expects “M&A to more closely resemble prior years with a total deal…

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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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Infliximab Clinical Trial Updates

The Big Molecule Watch is monitoring clinical trial activities involving infliximab.  Here we report on recent studies with Celltrion’s INFLECTRA (infliximab-dyyb). Earlier this year, clinical trial data was published from an observational real-world study of patients with inflammatory bowel disease, including Crohn’s disease (“CD”) and ulcerative colitis (“UC”) in the…

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