FDA Grants Interchangeable Designation to Yuflyma for Humira

The FDA has designated Yuflyma (Adalimumab-aaty; Celltrion, Inc.) as an interchangeable biosimilar to adalimumab (Humira; AbbVie). The biosimilar was approved by the FDA in May 2023 as a high-concentration (100 mg/mL) and citrate-free formulation of adalimumab to treat various inflammatory conditions as a recombinant fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody^.1,2

Image credit: CandyRetriever | stock.adobe.com

"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,” Thomas Nusbickel, chief commercial officer at Celltrion, said in a news release.¹

The designation was supported based on data from the randomized, double-blind, active-controlled phase 3 interchangeability study (NCT05495568) that demonstrated similar pharmacokinetics, efficacy, safety, and immunogenicity among individuals with moderate-to-severe active plaque psoriasis.^1,3

In the study, individuals with moderate-to-severe plaque psoriasis received 80 mg of the reference product on day 1 before receiving 40 mg 1 week later and every other week until week 11. At week 13, individuals were randomly assigned to either continue receiving the reference product or switch between the reference and the biosimilar until week 25. The study authors noted that the switching group received the biosimilar at weeks 13, 15, 21, 23, and 25, before switching to the reference product on weeks 17 and 19.⁴

The results demonstrated that at week 52, the overall average improvement in psoriasis severity score (PASI) from the start of the study was 90.34%. The safety of the drug was similar in both groups, and the development of antibodies against the drug did not increase during the open-label extension period (OLE). Additionally, at week 52, the average improvement in PASI score was slightly less in patients who had developed antidrug antibodies compared to those who had not. The improvements regarding how well the drug worked were seen up to week 27, continued during the OLE, and were comparable between the groups.⁴

"With this new designation, YUFLYMA is further positioned to help more patients gain access to and afford the therapy they need," Nusbickel said in the news release.¹

The 100 mg/mL dose of Yuflyma was approved for the treatment of 8 conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. Currently, Yuflyma is available as a 20-, 40-, and 80-mg solution for injection in a prefilled syringe and in an autoinjector pen.¹

REFERENCES

1. U.S. FDA grants interchangeable designation to YUFLYMA® (adalimumab-aaty), Celltrion's biosimilar to Humira® (adalimumab). Celltrion. News release. April 14, 2024. Accessed April 15, 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. Gallagher A. FDA Approves Celltrion’s Yuflyma as Humira Biosimilar for 8 Disease States. Pharmacy Times. May 25, 2023. Accessed April 15, 2025. https://www.pharmacytimes.com/view/fda-approves-celltroin-s-yuflyma-as-humira-biosimilar-for-8-disease-states

3. To Compare Pharmacokinetics, Efficacy, and Safety of CT-P17 With Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis. ClinicalTrials.gov identification: NCT05495568. Updated August 21, 2024. Accessed April 15, 2025. https://clinicaltrials.gov/study/NCT05495568

4. Dermatology and Therapy. CT-P17 Adalimumab Biosimilar in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: An Open-Label Extension of a Phase 3 Interchangeability Study. Published March 27, 2025. Accessed April 15, 2025. https://link.springer.com/article/10.1007/s13555-025-01383-5