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FDA Accepts Samsung Bioepis/Organon’s sBLA Seeking Interchangeability Designation for Adalimumab Biosimilar

Nov 7, 2023

Samsung Bioepis and Organon announced that the US FDA has accepted for review their Supplemental Biologics License Application (sBLA) seeking interchangeability designation for Hadlima™ (adalimumab-bwwd) injection 40 mg/0.4 mL, biosimilar to Humira® (adalimumab).  The sBLA was submitted to the FDA by Samsung Bioepis in August 2023.

Samsung Bioepis and Organon announced the interchangeability results for Hadlima™ in August .

The FDA has designated both Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm) and Pfizer’s Abrilada® as interchangeable biosimilars to Humira®.  The FDA has accepted Alvotech’s BLA for AVT02, its high concentration, interchangeable biosimilar, with a goal date of 24 February 2024.  Celltrion is also seeking an interchangeability designation for its approved biosimilar Yuflyma®, which it reported is tentatively expected in Q4 2024.