JERSEY CITY, N.J. — The U.S. Food and Drug Administration has granted interchangeability designation to HADLIMA™ (adalimumab-bwwd), a biosimilar to Humira®, for both its high- and low-concentration formulations. The designation allows pharmacists, subject to state laws, to substitute HADLIMA for Humira without consulting the prescribing physician, marking a significant milestone for expanding access to more affordable biologic therapies.
Developed by Samsung Bioepis and commercialized in the U.S. by Organon, HADLIMA is now recognized as interchangeable across all presentations of Humira, including autoinjectors, prefilled syringes, and single-dose vials. This follows earlier FDA approval for low-concentration forms and completes the designation for the entire HADLIMA product line.
The FDA’s decision is based on data from a randomized, double-blind clinical trial that evaluated pharmacokinetics, efficacy, safety, and immunogenicity in patients with moderate to severe plaque psoriasis. The study demonstrated comparable results between patients who switched between Humira and HADLIMA and those who remained on Humira throughout the trial.
“This designation underscores our commitment to making biosimilars more accessible to patients,” said Byoung In Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “It affirms that HADLIMA offers no clinically meaningful differences in safety, purity, or potency compared to Humira.”
Jon Martin, U.S. Commercial Lead for Biosimilars and Established Brands at Organon, emphasized the potential impact on patients. “Now fully interchangeable, HADLIMA offers an opportunity for increased access and potential savings,” he said. “Our data shows that patients paid, on average, more than four times as much out of pocket for Humira compared to HADLIMA. This designation can help reduce that burden.”
HADLIMA, a tumor necrosis factor (TNF) blocker, is approved for a wide range of inflammatory conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, psoriatic arthritis, hidradenitis suppurativa, uveitis, and ankylosing spondylitis.
Originally approved in 2019 as a low-concentration formulation, HADLIMA’s high-concentration version received FDA approval in 2022. Both versions have been available in the U.S. since 2023. With the new interchangeability designation, the biosimilar is now poised to play a larger role in the U.S. healthcare system by offering a more accessible and cost-effective alternative to Humira, one of the highest-grossing drugs globally.
