ICYMI: FDA Grants Adalimumab-aaty Interchangeability Designation; Celltrion Lowers WAC List Price

Celltrion, Inc. recently announced that the US FDA has expanded its interchangeable designation for adalimumab-aaty (Yuflyma), a high-concentration, citrate-free biosimilar to adalimumab (Humira; AbbVie).¹

The designation now includes all approved dosage forms and strengths, encompassing prefilled syringes (20 mg, 40 mg, 80 mg) and autoinjectors (40 mg, 80 mg).

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What the Interchangeability Designation Means

This latest FDA action means that Yuflyma may now be substituted for Humira across all dosage presentations, further enhancing its potential impact on reducing drug costs and streamlining access for patients.

"This full interchangeability designation comes at a pivotal time as Celltrion continues to lead in the evolving biosimilar landscape," said Thomas Nusbickel, chief commercial officer at Celltrion USA, in a news release.¹

Yuflyma is now among the select few adalimumab biosimilars in the US market with a comprehensive interchangeability designation. Its May 2023 FDA approval made it the 9th FDA-approved adalimumab biosimilar available to US patients.²

Clinical Foundations: The EADV-Presented Study

The FDA’s decision follows the results of a phase 3 clinical trial assessing Yuflyma’s performance against its reference biologic. The study, presented at the European Academy of Dermatology and Venereology Congress 2024, demonstrated that patients with moderately to severely active plaque psoriasis who transitioned between Humira and Yuflyma during the dosing interval (weeks 25 to 27) experienced no clinically meaningful differences in pharmacokinetics, efficacy, safety, or immunogenicity.

Clinical Indications and Expanded Patient Access

Yufluma was first approved for the treatment of several immune-mediated inflammatory conditions, including:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Ulcerative colitis
• Plaque psoriasis
• Hidradenitis suppurativa
• Uveitis
• Crohn disease in adults and pediatric patients aged 6 years and older
• Juvenile idiopathic arthritis in patients aged 2 years and older

Read more from Dermatology Times.

Celltrion also simultaneously announced an update to the wholesale acquisition cost for Yuflyma, which now stands at $948 per syringe.

The pricing adjustment aligns with recent US policy efforts aimed at curbing the cost of specialty drugs.³

References

1. Celltrion's YUFLYMA (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths. News release. PR Newswire. May 21, 2025. Accessed May 22, 2025. https://www.prnewswire.com/news-releases/celltrions-yuflyma-adalimumab-aaty-receives-fda-interchangeability-designation-for-all-its-approved-dosage-forms-and-strengths-302462600.html#:~:text=The%20expanded%20interchangeability%20designation%20for,efforts%20to%20lower%20drug%20prices
2. Celltrion USA announces US FDA approval of Yuflyma (adalimumab-aaty), a high-concentration and citrate-free formulation of Humira (adalimumab) biosimilar. News release. Healthcare Celltrion. Published May 24, 2023. Accessed May 22, 2025. https://www.celltrionhealthcare.com/board/en_newslist/102
3. Lowering drug prices by once again putting Americans first. The White House. April 15, 2025. Accessed May 22, 2025. https://www.whitehouse.gov/presidential-actions/2025/04/lowering-drug-prices-by-once-again-putting-americans-first/