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Organon, Samsung Bioepis announce FDA acceptace for review of Hadlima sBLA

Samsung Bioepis and Organon announced that the FDA has accepted for review the supplemental biologics license application, or sBLA, for the interchangeability designation for Hadlima injection 40 mg/0.4 mL, a biosimilar to Humira. The sBLA was submitted to the FDA by Samsung Bioepis in August 2023.

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