FDA Grants Expanded Interchangeability Designation to Yuflyma
Adalimumab-aaty (Yuflyma) prefilled syringes and autoinjectors are now fully interchangeable with the reference product adalimumab (Humira) across marketed dosage forms and strengths.
The FDA granted an expanded interchangeability designation for adalimumab-aaty (Yuflyma) to include prefilled syringes and autoinjectors, which are now fully interchangeable with the reference product, adalimumab (Humira), across marketed dosage forms and strengths. Adalimumab-aaty is a high-concentration, citrate-free biosimilar to Humira.1
Adalimumab-aaty (Yuflyma) prefilled syringes and autoinjectors are now fully interchangeable with the reference product adalimumab (Humira) across marketed dosage forms and strengths. | Image Credit: sunnychicka - stock.adobe.com
"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.1 "In alignment with recent federal initiatives aimed at lowering drug costs, we've taken timely action to enhance patient access and affordability. Yuflyma—a high-concentration, citrate-free adalimumab biosimilar now fully interchangeable with Humira—reflects our long-standing commitment to delivering high-quality, accessible treatment options."
Adalimumab-aaty was initially designated interchangeability status in early April 2025, and was approved in May 2023. The biosimilar is approved for multiple inflammatory indications, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, uveitis, Crohn disease, and juvenile idiopathic arthritis. The expanded designation builds on the phase 3 interchangeability study demonstrating similar outcomes in pharmacokinetics, efficacy, safety, and immunogenicity as adalimumab for patients with severely active plaque psoriasis. The data also showed similar efficacy for patients who switched between the reference product and the biosimilar.1,2
On the first day of the study, patients received the reference product, and at week 13, patients either continued the reference product or the biosimilar. The switching group received the biosimilar at weeks 13, 15, 21, 23, and 25 and received the reference product on weeks 17 and 19. There were 172 patients included in the switching group and 174 in the reference group. The data show that the primary pharmacokinetics were similar between the groups at week 27, as well as the secondary pharmacokinetic outcomes, including time to maximum serum concentrations between weeks 25 and 27, as well as up to week 52.2
The efficacy improvements for Psoriasis Area Severity Index (PASI) score were similar, with the mean improvements in the switching group being 88.1% and 87.7% in the continuous group, respectively, at week 13. At week 27, the improvements were 92.34% and 91.27%, respectively. PASI 50, 27, 90, and 100 for both groups were 95.99%, 86.6%, 61%, and 32%, respectively, in the switching group, and 96%, 85.5%, 59%, and 29.5%, respectively, in the continuous group at week 13.2
In results announced later in April 2025, adalimumab-aaty demonstrated continued results for treating moderate to severe chronic plaque psoriasis. Investigators conducted a repeated-switch study for 52 weeks. At week 13, patients began to receive either the reference product or the biosimilar until week 25. After week 25, patients entered the open-label extension, where they received adalimumab-aaty every other week. There was a total of 346 patients included in the final analysis, with 152 in the switching group and 160 in the continuous group. At week 52, investigators noted that psoriasis severity improved by an overall mean of 90.34%, according to the results.3
