FDA Grants Interchangeability Designation to Celltrion’s Humira Biosimilar Yuflyma
The interchangeability designation for Yuflyma, a biosimilar to Humira, may help to improve patient access and reduce costs.
Image Credit: Adobe Stock Images/Monchisa
The FDA has granted interchangeability designation to Celltrion’s Yuflyma (adalimumab-aaty), a high-concentration (100 mg/mL), citrate-free biosimilar of Humira (adalimumab), across multiple inflammatory indications. The designation allows pharmacists, subject to state laws, to substitute Yuflyma for Humira without prescriber intervention, which could potentially improve access and lower costs for patients.1
"With this new designation, Yuflyma is further positioned to help more patients gain access to and afford the therapy they need," said Thomas Nusbickel, chief commercial officer, Celltrion USA, in a press release. "Yuflyma has the same dosage form, route of administration, and dosing regimen as the reference product. The pharmacist's ability to substitute the biosimilar directly at the pharmacy without the hassle of a new prescription and without the patient having to learn a new method of administration can be a game changer in increasing patient access to adalimumab."
The FDA based the interchangeability designation on Phase III clinical trial data in patients with moderate-to-severe plaque psoriasis. The randomized, double-blind, active-controlled trial demonstrated comparable pharmacokinetics, efficacy, safety, and immunogenicity between Yuflyma and Humira. The study began with all patients receiving 80 mg subcutaneously of Humira on day one, followed by 40 mg a week later and every other week through week 11. At week 13, patients were randomly assigned to either continue on Humira or switch between Yuflyma and Humira until week 25. A total of 327 patients entered an open-label extension (OLE) to receive Yuflyma exclusively through week 49.
Results from the OLE showed that efficacy, as measured by the Psoriasis Area and Severity Index (PASI), was maintained through week 52. On average, patients achieved a 90.34% improvement from baseline. Safety and immunogenicity profiles remained consistent across groups, with no new safety concerns or increase in anti-drug antibody (ADA) development. At week 52, ADA-positive patients showed slightly lower PASI improvements compared to ADA-negative patients (89.57% vs. 97.29%), but both groups demonstrated robust clinical benefit, according to the trial investigators.2
Yuflyma was initially approved by the FDA in May 2023 based on a totality of evidence approach, including analytical, preclinical, and clinical data that confirmed its similarity to Humira in terms of efficacy, safety, and pharmacokinetics. The biosimilar is available in 20 mg, 40 mg, and 80 mg doses via prefilled syringes and autoinjector pens. Approved indications mirror those of Humira and include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.3
To support affordability, Celltrion offers two pricing models for the US market. The unbranded version, adalimumab-aaty, is listed at an 85% discount compared to Humira’s wholesale acquisition cost, while the branded Yuflyma is priced at a 5% discount. These options aim to support payer flexibility and expand patient access to biologic therapy.1
This latest approval marks another significant regulatory action for Celltrion in the past two months. In March, Celltrion received FDA approval for Omlyclo, (omalizumab-igec), the first and only biosimilar to Xolair (omalizumab), for moderate-to-severe persistent asthma, chronic rhinosinusitis with nasal polypsimmunoglobulin E-mediated food allergy, and chronic spontaneous urticaria.4 Earlier in March, the company also received FDA approval for Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo), biosimilars referencing Amgen’s Prolia and Xgeva, respectively.5
“Currently, more than 80% of patients treated with Humira in the United States rely on a high-concentration and citrate-free formulation of this medication,” said Jonathan Kay, professor, UMass Chan Medical School, in a 2023 press release regarding the initial approval of Yuflyma. “The availability of a high-concentration and citrate-free formulation adalimumab biosimilar provides an important treatment option for patients with inflammatory diseases who benefit from this effective therapy.”
References
1. U.S. FDA grants interchangeable designation to YUFLYMA® (adalimumab-aaty), Celltrion's biosimilar to Humira® (adalimumab). PR Newswire. April 14, 2025. Accessed April 16, 2025. https://www.prnewswire.com/news-releases/us-fda-grants-interchangeable-designation-to-yuflyma-adalimumab-aaty-celltrions-biosimilar-to-humira-adalimumab-302428226.html?tc=eml_cleartime
2. CT-P17 Adalimumab Biosimilar in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: An Open-Label Extension of a Phase 3 Interchangeability Study. Springer Nature. Accessed April 16, 2025. https://link.springer.com/article/10.1007/s13555-025-01383-5
3. Celltrion USA Announces U.S. FDA Approval of Yuflyma® (adalimumab-aaty), a High-Concentration and Citrate-Free Formulation of Humira® (adalimumab) Biosimilar. BusinessWire. May 24, 2023. Accessed April 16, 2025. https://www.businesswire.com/news/home/20230524005407/en/Celltrion-USA-Announces-U.S.-FDA-Approval-of-Yuflyma-adalimumab-aaty-a-High-Concentration-and-Citrate-Free-Formulation-of-Humira-adalimumab-Biosimilar
4. FDA Approves Celltrion’s Xolair Biosimilar Omlyclo for Multiple Indications. PharmExec. March 10, 2025. Accessed April 16, 2025. https://www.pharmexec.com/view/fda-approves-celltrion-xolair-biosimilar-omlyclo-multiple-indications
5. FDA Approves Celltrion’s Biosimilars Stoboclo and Osenvelt. PharmExec. March 4, 2025. Accessed April 16, 2025. https://www.pharmexec.com/view/fda-approves-celltrion-biosimilars-stoboclo-osenvelt
