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Organon announces FDA designates Hadlima as biosimilar to Humir

Samsung Bioepis and Organon (OGN) announced that the FDA has designated the Hadlima high- and low-concentration autoinjectors and high-concentration prefilled syringe as interchangeable biosimilars to Humira. These interchangeability designations follow the interchangeability designation received for the Hadlima low-concentration prefilled syringe and single-dose vial in June 2024.

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