FDA designates Organon's HADLIMA as interchangeable biosimilar to Humira across all presentations

Organon & Co.

FDA granted interchangeability for HADLIMA high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe.
HADLIMA is now interchangeable with all formulations of Humira, including low-concentration prefilled syringe and single-dose vial (granted June 2024).
Designation based on PK, efficacy, safety, and immunogenicity study of SB5 vs Humira in moderate to severe plaque psoriasis patients.
Interchangeability allows pharmacists to substitute HADLIMA for Humira without consulting prescriber, subject to state pharmacy laws.
Average patient out-of-pocket cost for Humira was more than four times that of HADLIMA, per Organon data.

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