Big Molecule Watch
July 6, 2023

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 are now 8 adalimumab biosimilar products available in the U.S. market.

Each of the new adalimumab biosimilar products are offered in autoinjector and prefilled syringe options.  CYLTEZO, YUSIMRY, IDACIO, and HULIO are available as a 50 mg/ml formulation, YUFLYMA is available as a 100 mg/ml formulation, and HYRIMOZ and HADLIMA are available as both 50 mg/ml and 100 mg/ml formulations.  Boehringer Ingelheim’s CYLTEZO is the only approved adalimumab biosimilar that FDA has approved as interchangeable to HUMIRA.

Pfizer’s ABRILADA (adalimumab-afzb) is also expected to launch in 2023.

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