FDA Grants Yuflyma Interchangeability Designation for Humira
The FDA approved adalimumab-aaty in May 2023 for 8 indications, including rheumatoid arthritis, psoriatic arthritis, Crohn disease, ulcerative colitis, and plaque psoriasis.
The FDA designated adalimumab-aaty (Yuflyma) as an interchangeable biosimilar to adalimumab (Humira). Adalimumab-aaty was approved in May 2023 as a high-concentration (100 mg/mL), citrate-free biosimilar formulation.1,2
The FDA approved adalimumab-aaty in May 2023 for 8 indications, including rheumatoid arthritis, psoriatic arthritis, Crohn disease, ulcerative colitis, and plaque psoriasis. | Image Credit: sunnychicka - stock.adobe.com
"With this new designation, Yuflyma is further positioned to help more patients gain access to and afford the therapy they need," Thomas Nusbickel, chief commercial officer at Celltrion USA, said in a news release.1 "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 designation was supported by data from a phase 3 interchangeability study, demonstrating similar outcomes in pharmacokinetics, efficacy, safety, and immunogenicity for patients with moderate to severely active plaque psoriasis. Patients either continued to receive the reference product or alternated between the biosimilar and reference product during the dosing interval weeks 25 through 27.1
On the first day of the study, patients in both groups received the reference product. At week 13, patients either continued the reference product or received the biosimilar. The switching group received the biosimilar at week 13, 15, 21, 23, and 25 and received the reference product on week 17 and 19, according to the clinical trial information.3
The primary outcomes included evaluating the pharmacokinetics between the patient groups using the area under the concentration-time curve over the dosing interval and the maximum serum concentration during the dosing interval. The secondary end points included pharmacokinetics of time to maximum serum concentration between weeks 25 and 27 and up to week 52, mean improvement from baseline in Psoriasis Area Severity Index (PASI) score up to week 52, proportion of patients with at least a 50%, 75%, 90%, and 100% improvement in PASI score, proportion of patients with static physician’s global assessment score of 0 (clear) or 1 (almost clear), and evaluation of adverse events (AEs).3
There were 172 patients in the switching group and 174 in the reference product group, with 5.8% and 3.4%, respectively, discontinuing the study drug. Investigators reported that the primary pharmacokinetics were similar between both groups at week 27, as well as secondary pharmacokinetic end points. The efficacy improvements in PASI score were also similar between the treatment groups, with the mean improvements at week 13 being 88.1% in the switching group and 87.7% in the continuous group. At week 27, the improvements were 92.34% and 91.27%, according to the investigators.4
Furthermore, for PASI 50, 75, 90, and 100, both groups were also similar, demonstrating 95.99%, 86.6%, 61%, and 32%, respectively, for the switching group and 96%, 85.5%, 59%, and 29.5%, respectively, at week 13. As for safety, the most commonly occurring treatment-emergent AEs included upper respiratory tract infection, alanine aminotransferase increase, hypertriglyceridemia, and nasopharyngitis.4
The FDA approved it for 8 indications, which align with the reference product, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. The biosimilar is available as a prefilled syringe and autoinjector pen.2
READ MORE: Biosimilar Resource Center
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