Celltrion’s YUFLYMA (adalimumab-aaty) Receives FDA Interchangeable Designation as Biosimilar to Humira (adalimumab)

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On April 14, 2025, Celltrion announced that it was granted interchangeable designation by FDA for its adalimumab-aaty (brand name YUFLYMA), a biosimilar to adalimumab (brand name Humira). Adalimumab-aaty is approved by FDA as a high-concentration (100mg/mL) and citrate-free formulation of the adalimumab reference biologic for treating multiple inflammatory indications (1).

FDA approved the high-concentration adalimumab-aaty formulation in May 2023 (2). It has been made available as 20mg, 40mg, and 80mg solution for injection in a prefilled syringe and in an autoinjector pen, following market launch in the United States in July 2023.

"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, in a company press release (1). "YUFLYMA has the same dosage form, route of administration, and dosing regimen as the reference product.”

FDA’s interchangeable designation was based on data from a Phase III interchangeability study. In the study, adalimumab-aaty demonstrated similar outcomes in terms of pharmacokinetics, efficacy, safety, and immunogenicity. The study was conducted in patients with moderately to severely active plaque psoriasis who received reference adalimumab (ADA) continuously and those who alternated between reference ADA and adalimumab-aaty during the dosing interval (Week 25–27).

FDA-approved interchangeable biosimilars may be substituted for the reference product at the pharmacy without the need for intervention by the prescribing healthcare provider, subject to state laws (3).

“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," said Nusbickel in the release.

Adalimumab-aaty is a recombinant, fully human anti-tumor necrosis factor α (anti-TNFα) monoclonal antibody. According to Celltrion in its press release, it is also the first proposed high-concentration, low-volume, and citrate-free adalimumab biosimilar worldwide to receive European Commission approval. Under FDA’s approval, it is indicated for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

Adalimumab-aaty’s approved indications specifically apply to the following:

• rheumatoid arthritis (RA)—for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA
• juvenile idiopathic arthritis (JIA)—for reducing signs and symptoms of moderately to severely active polyarticular JIA in patients age two years and older
• psoriatic arthritis (PsA)—for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA
• ankylosing spondylitis (AS)—for reducing signs and symptoms in adult patients with active AS
• Crohn's disease (CD)—for treating moderately to severely active CD in adults and pediatric patients age six years and older
• ulcerative colitis (UC)—for treating moderately to severely active UC in adults
• plaque psoriasis (Ps)—for treating adult patients with moderate to severe chronic Ps who are candidates for systemic therapy or phototherapy when other systemic therapies are medically less appropriate
• hidradenitis suppurativa (HS)—for treating adult patients with moderate to severe HS
• uveitis—for treating non-infectious intermediate, posterior, and panuveitis in adult patients.

References

1. Celltrion. US FDA grants interchangeable designation to YUFLYMA® (adalimumab-aaty), Celltrion's biosimilar to Humira (adalimumab). Press Release. April 14, 2025.
2. Celltrion. Celltrion USA Announces US FDA Approval of Yuflyma (adalimumab-aaty), a High-Concentration and Citrate-Free Formulation of Humira (adalimumab) Biosimilar. Press Release. May 24, 2023.
3. FDA. 9 Things to Know About Biosimilars and Interchangeable Biosimilars. fda.gov (accessed April 17. 2025).