HADLIMA Cleared for Substitution with Humira in All Forms: FDA

Key Takeaways

• FDA granted full interchangeability status to all HADLIMA presentations with Humira.

• The expanded designation is based on robust clinical trial data in plaque psoriasis patients.

The US Food and Drug Administration (FDA) has granted full interchangeability status to adalimumab-bwwd (HADLIMA™), a biosimilar of Humira® (adalimumab), across all forms and concentrations, according to a press release from Organon.

According to the news release, pharmacists in many states can now substitute HADLIMA for Humira without prescriber intervention. This follows earlier approval of HADLIMA's low-concentration prefilled syringe and vial in June 2024. The FDA’s decision now includes HADLIMA’s high- and low-concentration injectors (40 mg/0.4 mL and 40 mg/0.8 mL) and the high-concentration prefilled syringe.

Data for the approval were drawn from a double-blind, parallel-group clinical trial in patients with moderate to severe plaque psoriasis, in which the researchers examined pharmacokinetics, efficacy, safety, and immunogenicity between patients who switched between Humira and a HADLIMA biosimilar vs. those remaining on Humira. Results showed comparable outcomes across all endpoints.

“This designation is meaningful as it signifies our continued commitment to making biosimilars more accessible. Both biosimilars and interchangeable biosimilars are highly similar and have no clinically meaningful differences in safety, purity, and potency compared to the reference product,”said Byoung In Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis, in the press release. “With this designation, we continue to benefit patients, health care providers, and health care systems around the world.”

HADLIMA is manufactured by Samsung Bioepis and commercialized by Organon.

Source: Organon press release. May 27, 2025.