Samsung Bioepis And Organon Say FDA Designates HADLIMA High- And Low-Concentration Autoinjectors And High-Concentration Prefilled Syringe As Interchangeable Biosimilars To Humira

Author: Benzinga Newsdesk | May 27, 2025 07:32am

• HADLIMA™ (adalimumab-bwwd) injection, 40 mg/0.4 mL & 40 mg/0.8 mL is now interchangeable with all high- and low-concentration presentations (autoinjector, prefilled syringe, and single-dose vial) of Humira (adalimumab)
• The interchangeability designation for HADLIMA is based on a Pharmacokinetics, Efficacy, Safety, and Immunogenicity study of SB5 versus Humira in patients with moderate to severe chronic plaque psoriasis
• An interchangeable biosimilar product may be substituted for the reference product without consulting the prescriber, subject to state pharmacy laws

Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE:OGN) today announced that the US Food and Drug Administration (FDA) has designated the HADLIMA™ (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe as interchangeable biosimilars to Humira® (adalimumab). These interchangeability designations follow the interchangeability designation received for the HADLIMA low-concentration (40 mg/0.8 mL) prefilled syringe and single-dose vial in June 2024.1 With today's additional interchangeability designations, HADLIMA is now interchangeable with all presentations of the reference product. An interchangeability designation enables a pharmacist to substitute the reference product with a biosimilar without the need to consult the prescriber, depending on state pharmacy laws.

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