Rebecca L. Forand , 2025-04-15 17:00:00
April 15, 2025
1 min read
Key takeaways:
- Celltrion’s Yuflyma is a high concentration, citrate-free formulation of adalimumab.
- It is the ninth Humira biosimilar approved by the FDA and the fourth to receive interchangeability status.
The FDA has accepted Yuflyma as an interchangeable biosimilar to adalimumab for the treatment of multiple chronic inflammatory diseases, Celltrion USA announced in a press release.
A high-concentration (100mg/mL), citrate-free formulation of Humira (adalimumab, AbbVie), Yuflyma (adalimumab-aaty, Celltrion USA) is the ninth biosimilar to adalimumab approved by the FDA and the fourth to be accepted for all indications of the reference product: adult Crohn’s disease, ulcerative colitis, rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis and hidradenitis suppurativa.
The FDA has accepted Yuflyma as an interchangeable biosimilar to adalimumab in all indications.
With this approval, pharmacies can substitute Yuflyma for originator Humira without consulting prescribers — at least where such policies are allowed under state law.
“Yuflyma has the same dosage form, route of administration and dosing regimen as the reference product,” Thomas Nusbickel, chief commercial officer at Celltrion USA, said in the release. “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 FDA based its decision on data from a phase 3 interchangeability study, which found that patients with moderate to severe plaque psoriasis who were treated continuously with Humira experienced similar efficacy, safety and immunogenicity as those who alternated between Humira and Yuflyma treatments during weeks 25-27.
Yuflyma is available as a 20 mg, 40 mg and 80 mg solution for injection in both a prefilled syringe and autoinjector pen.