Celltrion’s autoimmune disease treatment Yuflyma can now be used as an interchangeable substitute for Humira in the United States without a physician’s prescription.
Celltrion announced on April 14 that the U.S. Food and Drug Administration (FDA) has granted interchangeability designation for Yuflyma(adalimumab) and the reference biologic, Humira.
The U.S. interchangeability system allows biosimilars with proven equivalent efficacy and safety to be substituted for originator biologics at the pharmacy level, without requiring a new prescription. Once granted this status, a pharmacist can automatically dispense the biosimilar in place of the reference drug.
Celltrion submitted its application for interchangeability based on global clinical trial results involving 367 patients with moderate to severe plaque psoriasis, demonstrating equivalence between Yuflyma and Humira.
With this approval, Yuflyma gains a competitive edge in the U.S. market, as it is now authorized for pharmacy-level substitution. In the U.S. prescription system, which typically relies on ingredient names rather than brand names, this designation is expected to significantly boost market share, the company explained.
Yuflyma, developed by Celltrion, is a high-concentration, citrate-free biosimilar of Humira. It requires only half the volume of the low-concentration version and is designed to reduce injection site pain. The product has been expanding its market share across Europe through tailored bidding strategies and is rapidly building distribution channels in the U.S. using a dual pricing model.
Humira, the reference biologic for Yuflyma, recorded $8.993 billion in global sales last year, with $7.142 billion—about 80%—coming from the U.S. alone.
A Celltrion spokesperson commented, “With this interchangeability approval, Yuflyma’s competitiveness in the rapidly growing U.S. market will be further enhanced. We will continue to do our utmost to improve access to Yuflyma and solidify its presence in the world’s largest adalimumab market.”
