The FDA has granted interchangeability designation to Hadlima (adalimumab-bwwd) as a biosimilar to Humira.¹ Developed by Samsung Bioepis and commercialized by Organon, the parties’ high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe are being deemed interchangeable biosimilars.

Interchangeability designation allows a pharmacist to substitute the reference product with a biosimilar without having to discuss with the prescriber prior (depending on state law).²

Capitalizing on momentum

This development follows up on the momentum garnered from June of last year, in which Hadlima’s low-concentration (40 mg/0.8 mL) prefilled syringe and single-dose vial had received the same designation.

The latest award means that Hadlima is now officially fully interchangeable with all reference product presentations. In 2019, it was first approved by the FDA in as a low-concentration (40 mg/0.8 mL) formulation of prefilled syringe and autoinjector. The high-concentration (40 mg/0.4 mL) formulation of prefilled syringe and autoinjector of Hadlima was then approved three years later, with formulations being commercially available in the United States since 2023.

“An increased uptake of biosimilars may lead to improved patient access to biologic therapies and potential savings for the US health care system. As a company dedicated to making medicines more accessible, HadlimA, now designated as fully interchangeable with the reference product, has a greater potential to bring savings for patients. As our data shows, on average, patients paid more than four times as much out of pocket per month for Humira compared to Hadlima,”, noted Jon Martin, US commercial lead, biosimilars and established brands at Organon. “With this approval, pharmacies can substitute Hadlima for the reference product Humira without consulting prescribers (subject to state law), which may facilitate increased access for patients to receive the medications they need.”

Defining Hadlima

Hadlima is considered a tumor necrosis factor (TNF) blocker for patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. The aforementioned designation was awarded following clinical data from a randomized, double-blind, 1:1 ratio, parallel-group, multiple-dose clinical trial,³ which measured pharmacokinetics (PK), efficacy, safety, and immunogenicity in two treatment groups:

1. Patients with moderate to severe plaque psoriasis who switched between formulations of EU-sourced Humira and high-concentration SB5 (adalimumab biosimilar)
2. Patients who continuously received Humira

The study showed that the switching group and the continuous Humira treatment group had comparable primary pharmacokinetic endpoints, along with similar efficacy, safety, and immunogenicity profiles.

“This designation is meaningful as it signifies our continued commitment to making biosimilars more accessible,” said Byoung In Jung, vice president and regulatory affairs team leader at Samsung Bioepis. “Both biosimilars and interchangeable biosimilars are highly similar and have no clinically meaningful differences in safety, purity, and potency compared to the reference product. With this designation, we continue to benefit patients, healthcare providers, and healthcare systems around the world.”

References

1. US Food and Drug Administration (FDA) Grants Interchangeability Designation to Samsung Bioepis and Organon Hadlima (adalimumab-bwwd) Injection. Business Wire. May 27, 2025. Accessed May 29, 2025. https://www.businesswire.com/news/home/20250527970852/en/US-Food-and-Drug-Administration-FDA-Grants-Interchangeability-Designation-to-Samsung-Bioepis-and-Organon-HADLIMA-adalimumab-bwwd-Injection

2. US Food and Drug Administration. Biosimilar and interchangeable biologics; more treatment choices. Updated August 17, 2023. Accessed May 29, 2025. https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices

3. Feldman S, Valiukeviciene S, Pulka G, et al. Interchangeability of SB5 and adalimumab reference product in patients with moderate to severe chronic plaque psoriasis. Poster presented at: American Academy of Dermatology Annual Meeting; March 8-12, 2024; San Diego, CA. Accessed May 2025. https://eposters.aad.org/abstracts/50522