FDA grants interchangeable designation for Celltrion’s Yuflyma

The Food and Drug Administration has designated Celltrion’s Yuflyma (adalimumab-aaty), as an interchangeable biosimilar to Abbvie's Humira (adalimumab). 

Yuflyma is a 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, chief commercial officer 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."

[Read more: Celltrion receives FDA nod for Prolia, Xgeva biosimilars]

The high-concentration form of Yuflyma was FDA-approved in May 2023 and is currently available as 20 mg, 40 mg and 80 mg 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.

Yuflyma is available in two pricing options to help provide more affordable options for patients. Adalimumab-aaty, the unbranded version, is priced at an 85% discount to the current wholesale acquisition cost list price of Humira (adalimumab), providing economic benefits for patients and overall healthcare system. The branded version is priced at a 5% discount to the current WAC of Humira, the company said.

[Read more: FDA approves Celltrion's Xolair biosimilar]