Tagged as: Cyltezo

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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Recent Adalimumab Biosimilar Developments

FDA grants interchangeable designation to Pfizer’s adalimumab biosimilar – On October 5, 2023, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has designated ABRILADA (adalimumab-afzb) as an interchangeable biosimilar to HUMIRA (adalimumab). ABRILADA was originally approved by the FDA in November 2019. The new interchangeable designation was…

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HUMIRA (adalimumab) Biosimilar Launches

In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. market:  Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm); Sandoz’s HYRIMOZ (adalimumab-adaz); Organon and Samsung Bioepis’s HADLIMA (adalimumab-bwwd); Coherus Biosciences’s YUSIMRY (adalimumab-aqvh); Celltrion’s YUFLYMA (adalimumab-aaty); Fresenius Kabi’s IDACIO (adalimumab-aacf); and Biocon’s HULIO (adalimumab-fkjb).  With Amgen’s AMJEVITA (adalimumab-atto), launched in January 2023, there…

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CYLTEZO® to Launch on July 1 as the First Interchangeable HUMIRA® Biosimilar

Beginning tomorrow, July 1, 2023, CYLTEZO® (adalimumab-adbm) will become the first HUMIRA® (adalimumab) biosimilar with interchangeable status to be commercially available in the United States.  Boehringer Ingelheim has also announced that with CYLTEZO’s commercial launch, pharmacy-benefit manager Optum Rx (a subsidiary of UnitedHealth Group), which currently covers more than 66…

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FDA Approves the Cyltezo Pen, an Autoinjector Option for Adalimumab

On May 22, 2023, Boehringer Ingelheim announced that the FDA has approved the Cyltezo Pen, a new autoinjector option for Cyltezo (adalimumab-adbm). According to a previous announcement from Boehringer Ingelheim, Cyltezo is an FDA-approved Interchangeable biosimilar to Humira (adalimumab) and its commercial license will begin on July 1, 2023. Initially…

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Boehringer Ingelheim Announces Positive Phase III Results for Its Adalimumab Biosimilar

On September 12, 2018, Boehringer Ingelheim announced positive results from a Phase III clinical trial for its approved adalimumab biosimilar, Cyltezo®. The clinical trial compared the efficacy, safety and immunogenicity of Cyltezo® and Humira® in patients with moderate-to-severe chronic plaque psoriasis.  According to Boehringer Ingelheim, the study confirmed equivalence of Cyltezo®…

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