FDA Grants Interchangeability Designation to Adalimumab-Bwwd for Humira
This designation follows Hadlima’s low-concentration prefilled syringes and single-dose vials, which were designated in June 2024.
The FDA granted interchangeability designation to adalimumab-bwwd (Hadlima) as both high and low concentrations of adalimumab (Humira). The biosimilar is also approved as autoinjectors and a high-concentration prefilled syringe. This designation followed Hadlima low-concentration prefilled syringes and single-dose vials, which were designated in June 2024.1
This designation follows Hadlima’s low-concentration prefilled syringes and single-dose vials, which were designated in June 2024. | Image Credit: lexiconimages - stock.adobe.com
“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,” Jon Martin, commercial lead of biosimilars and established brands at Organon, said in a news release.1 “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.”
The biosimilar is approved for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. The designation was based on clinical data from a randomized, double-blind 1:1 ratio clinical trial that assessed the pharmacokinetics, efficacy, safety, and immunogenicity for both treatment groups, including patients with plaque psoriasis between formulations of EU-sourced Humira and the high-concentration biosimilar compared with patients receiving Humira.1
Investigators found that the primary pharmacokinetic end points between both groups were comparable. Further, the efficacy, safety, and immunogenicity profiles were also similar for the switching and continuous treatment groups, according to the findings from the study.1
“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,” Byoung In Jung, vice president and regulatory affairs team leader at Samsung Bioepis, said in the news release.2 “With this designation, we continue to benefit patients, health care providers, and health care systems around the world.”
The biosimilar was first available in July 2023, and the citrate-free, high-concentration was approved at the same time. In May 2025, the FDA also granted expanded interchangeability designation for adalimumab-aaty (Yuflyma) for prefilled syringes and autoinjectors for Humira. It is also a high-concentration, citrate-free biosimilar marketed across all dosage forms and strengths.2-4
Adalimumab-aaty was initially designated interchangeability status in early April 2024 and was approved in May 2023. The biosimilar is also approved for the same indications as the reference product.4
"This full interchangeability designation comes at a pivotal time as Celltrion continues to lead in the evolving biosimilar landscape," Thomas Nusbickel, chief commercial officer at Celltrion USA, said in a news release.4
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REFERENCES
1. US Food and Drug Administration (FDA) Grants Interchangeability Designation to Samsung Bioepis and Organon Hadlima (adalimumab-bwwd) Injection. News release. Organon. May 27, 2025. Accessed May 27, 2025. https://www.organon.com/news/us-food-and-drug-administration-fda-grants-interchangeability-designation-to-samsung-bioepis-and-organon-hadlima-adalimumab-bwwd-injection/
2. Biscaldi L. Five Adalimumab Biosimilars Now Available in US Market. Drug Topics. July 5, 2023. Accessed May 27, 2025. https://www.drugtopics.com/view/five-adalimumab-biosimilars-now-available-in-us-market
3. Samsung Bioepis and Organon Announce FDA Approval of Citrate-Free High-Concentration Humira Biosimilar Hadlima (adalimumab-bwwd). News release. Organon. August 17, 2022. Accessed May 27, 2025. https://www.organon.com/news/samsung-bioepis-and-organon-announce-fda-approval-of-citrate-free-high-concentration-humira-biosimilar-hadlima-adalimumab-bwwd/
4. Gallagher A. FDA Grants Expanded Interchangeability Designation to Yuflyma. Drug Topics. May 23, 2025. Accessed May 27, 2025. https://www.drugtopics.com/view/fda-grants-expanded-interchangeability-designation-to-yuflyma
