Organon (OGN) and Samsung Bioepis Announce FDA Approval of HADLIMA
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Samsung Bioepis and Organon Announce FDA Approval of Citrate-Free High-Concentration HUMIRA® Biosimilar HADLIMA™ (adalimumab-bwwd)
August 17, 2022 7:30 AM EDTINCHEON, Korea & JERSEY CITY, N.J.--(BUSINESS WIRE)-- Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced the U.S. Food and Drug Administration (FDA) has approved the citrate-free, high-concentration (100 mg/mL) formulation of HADLIMA (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab). HADLIMA will be available in pre-filled syringe and autoinjector options, and the autoinjector was specifically designed with the patient in mind. HADLIMA was previously approved by the FDA as a low-concentration (50 mg/mL) formulation in July 2019 and outside the US that formulation has been available in various markets globally... More
