FDA Grants Interchangeable Designation to Adalimumab Biosimilar CT-P17 (Yuflyma)

An announcement has been released that the US Food and Drug Administration (FDA) granted interchangeable biosimilar status to CT-P17 (Yuflyma), also known as adalimumab-aaty, which was designed as a high-concentration (100 mg/mL), citrate-free formulation of adalimumab (Humira).1

The April 15 announcement by Celltrion, Inc. describes the designation as confirmation that CT-P17 can be substituted for adalimumab at the pharmacy level, depending on individual state regulations, without the prescriber authorization that would otherwise be required. CT-P17 is FDA-approved for utilization in a variety of inflammatory conditions, including plaque psoriasis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, and uveitis.

"With this new designation, [CT-P17] 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 statement.1

The treatment itself is a recombinant, fully human monoclonal antibody designed to target tumor necrosis factor alpha (TNFα). CT-P17 is available in 3 strengths: 20 mg/0.2 mL, 40 mg/0.4 mL, and 80 mg/0.8 mL. The decision by the FDA to approve it as a biosimilar to adalimumab resulted from a phase 3 interchangeability trial evaluating patients with moderate-to-severe plaque psoriasis.

"[CT-P17] has the same dosage form, route of administration, and dosing regimen as the reference product,” Nusbickel said in a statement.1 “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."

Following the study’s conclusion, investigators reported that trial participants involved who alternated between reference adalimumab and CT-P17 during Weeks 25–27 demonstrated a lack of meaningful differences in efficacy, pharmacokinetics, safety, or immunogenicity versus participants who remained on reference adalimumab throughout.

Such findings were presented at the 2024 European Academy of Dermatology and Venereology (EADV) meeting as well.2 CT-P17 was approved by FDA officials in May 2023 as a low-volume, high-concentration, citrate-free biosimilar. The medication was launched in the US commercial market in July 2023, offered in prefilled syringes and autoinjector pens for patients in 20 mg, 40 mg, and 80 mg doses.

Along with its approval in the US, CT-P17 also became the first proposed high-concentration adalimumab biosimilar to be provided with marketing authorization from the European Commission. The drug is being offered in 2 pricing models, with the aim being to support patient access and affordability.

The unbranded adalimumab-aaty version was noted in Celltrion’s announcement as available at an 85% discount compared to the current wholesale acquisition cost of adalimumab, whereas the branded version is priced at a 5% discount to adalimumab’s wholesale acquisition cost.1

References

1. U.S. FDA grants interchangeable designation to YUFLYMA® (adalimumab-aaty), Celltrion's biosimilar to Humira® (adalimumab). Celltrion, Inc. April 14, 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. Lebwohl M et al., Pharmacokinetics, Efficacy and Safety after Multiple Switches from Reference Adalimumab to Adalimumab Biosimilar (CT-P17) in comparison with the Maintenance Group (Reference Adalimumab) in Patients with Moderate-toSevere Plaque Psoriasis: Week 27 Results from the Phase III Interchangeability Study. [EADV 2024, Poster number P0931]. Available at: https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.eadv/abstracts_congress_2024/41489.pdf.