Tagged as: Organon

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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Samsung Bioepis and Organon Announce FDA Approval of Citrate-Free, High-Concentration Adalimumab Biosimilar

Last week Samsung Bioepis and Organon announced FDA approval of their citrate-free, high-concentration (100 mg/ml) HUMIRA biosimilar, HADLIMA (adalimumab-bwwd).  HADLIMA was previously approved by FDA as a low concentration (50 mg/ml) formulation in July 2019.  The low-concentration product has been available in various markets outside the United States, with over…

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Merck Completes Organon Spinoff

As we previously reported, earlier this year Merck announced that it would be spinning off its women’s health, biosimilars, and established brands businesses into a standalone company.   This month, Merck completed the spinoff, creating Organon.  Organon’s portfolio contains about 60 treatments and products, and mainly focuses on ex-US markets.  Organon…

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