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Yuflyma gains FDA interchangeability with Humira, enhancing patient access to effective biosimilar treatments for various inflammatory conditions.
The FDA has expanded interchangeable designation for adalimumab-aaty (Yuflyma; Celltrion, Inc), a reference product for adalimumab (Humira; AbbVie), which now includes a 40 mg prefilled syringe, along with 40 mg and 80 mg autoinjectors, marking the product as a fully interchangeable biosimilar across all marketed dosage forms and strengths.1
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As a high-concentration, low-volume, and citrate-free adalimumab biosimilar, Yuflyma is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis in adult patients; Crohn disease in adults and pediatric patients aged 6 and older; and juvenile idiopathic arthritis in patients aged 2 and older.1
An interchangeable biosimilar is a type of biosimilar that can be substituted for the reference product at the pharmacy level without consulting the prescriber, depending on state laws. Both biosimilars and interchangeable biosimilars meet the same FDA standards for safety and effectiveness, and the interchangeability designation does not imply a higher quality or greater efficacy.4
Currently, Yuflyma is available in prefilled syringes as 20 mg/0.2 mL, 40 mg/0.4 mL, and 80 mg/0.8 mL, along with the expanded interchangeability as a 40 mg/0.4 mL and 80 mg/0.8 mL autoinjector.1
The biosimilar was previously 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 monoclonal antibody.2
Additionally, in April 2025, the FDA designated Yuflyma as an interchangeable biosimilar to Humira, which was supported based on data from a randomized, double-blind, active-controlled phase 3 interchangeability study (NCT05495568). The results demonstrated similar pharmacokinetics, efficacy, safety, and immunogenicity among individuals with moderate-to-severe active plaque psoriasis.3
"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 USA, said in a news release.3
In the phase 3 study, individuals received an 80 mg dose of a reference product, followed by 40 mg doses every other week until week 11. At week 13, some participants continued the reference product, while others switched between the reference and a biosimilar. By week 52, the overall average improvement in psoriasis severity was 90.34%. The drug’s safety was consistent across both groups, and there was no increase in antidrug antibodies during the open-label extension. While patients with antidrug antibodies showed slightly less improvement, the drug’s effectiveness remained comparable between groups up to week 27 and throughout the open-label extension.3
The study authors noted that the current interchangeable designation builds on the results highlighted in this phase 3 study, which were presented at the European Academy of Dermatology & Venereology in Paris, France in September 2024.1
Celltrion has reduced the wholesale acquisition cost list price of Yuflyma to $948 per syringe, effective immediately, with updated pricing already submitted to national compendia, according to the news release.1
"In alignment with recent federal initiatives aimed at lowering drug costs, we've taken timely action to enhance patient access and affordability,” Nusbickel said in the news release.1
