Tagged as: Humira

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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Regulatory Update on Alvotech’s AVT02, a High-Concentration Interchangeable Adalimumab Biosimilar

On September 20, Alvotech announced that FDA has accepted the resubmission of its Biologics License Application (BLA) for AVT02, a high concentration, interchangeable biosimilar to HUMIRA (adalimumab). FDA has set a Biosimilar User Fee Act (BsUFA) goal date for approval of the resubmitted AVT02 BLA of February 24, 2024.  As…

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Teva and Alvotech Expand Strategic Biosimilars Partnership

Alvotech and Teva announced an expansion of their existing strategic partnership agreement relating to biosimilars products in the U.S.  According to the announcement, the existing agreement includes AVT02, an interchangeable high-concentration biosimilar candidate for HUMIRA (adalimumab), and four other biosimilar candidates, including AVT04, a proposed biosimilar of STELARA (ustekinumab).  The…

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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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Coherus and AbbVie File Dueling Motions for Injunctive Relief Relating to Coherus’s HUMIRA Biosimilar

Our readers may recall that ten HUMIRA biosimilars have been licensed to launch, with Amgen’s AMJEVITA the only one to launch to date and nine others set to launch starting in July 2023.  On June 1, 2023, Coherus issued a press release announcing “that the company plans to launch YUSIMRY™…

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