The U.S. Food and Drug Administration (FDA) has designated Celltrion Inc.’s YUFLYMA (adalimumab-aaty), as an interchangeable biosimilar to Humira (adalimumab). YUFLYMA is an FDA-approved, high-concentration (100mg/mL) and citrate-free formulation of Humira biosimilar, approved for multiple inflammatory indications.

“With this new designation, YUFLYMA is further positioned to help more patients gain access to and afford the therapy they need,” said Thomas Nusbickel, CCO at Celltrion USA. “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 interchangeable designation was supported by data from the Phase III interchangeability study, which demonstrated similar outcomes in terms of pharmacokinetics, efficacy, safety and immunogenicity in patients with moderately to severely active plaque psoriasis who received reference adalimumab (ADA) continuously and those who alternated between reference ADA and YUFLYMA during the dosing interval of Week 25-27.

The high-concentration form of YUFLYMA was FDA-approved in May 2023 and is currently available as 20mg, 40 mg and 80mg solution for injection in a prefilled syringe and in an autoinjector pen. YUFLYMA was introduced into the U.S. commercial market on July 2, 2023.

Celltrion’s biosimilars referencing Prolia, Xgeva and ACTEMRA were also approved earlier this year.