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Celltrion's YUFLYMA® Achieves Expanded FDA Interchangeability Designation

On May 21, 2025, Celltrion, Inc. announced a significant milestone for its biosimilar product, YUFLYMA® (adalimumab-aaty), as it has received an expanded interchangeable designation from the U.S. Food and Drug Administration (FDA). This designation now encompasses all approved dosage forms and strengths of YUFLYMA, including newly added presentations such as the prefilled syringe of 40mg and the autoinjectors of both 40mg and 80mg.

This designation positions YUFLYMA as fully interchangeable with the reference product, Humira® (adalimumab). This change is crucial for patients as it enhances their access to effective treatment options, especially amid increasing efforts to lower prescription drug costs across the country. Thomas Nusbickel, the Chief Commercial Officer at Celltrion USA, emphasized the importance of this development. He stated, "This full interchangeability designation comes at a pivotal time as Celltrion continues to lead in the evolving biosimilar landscape. We aim to provide high-quality, accessible treatment options, reflecting our long-standing commitment to patient care."

Understanding YUFLYMA®

YUFLYMA is a high-concentration, citrate-free biosimilar formulation of Humira, used in treating various inflammatory conditions, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), ulcerative colitis (UC), and more. The product not only improves treatment accessibility but also works to align with new federal initiatives aimed at reducing overall drug expenses for consumers.

The interchangeability of YUFLYMA is backed by robust clinical research. A Phase III study demonstrated comparable results in pharmacokinetics, efficacy, safety, and immunogenicity between patients receiving the original adalimumab continuously and those switching between the reference and YUFLYMA over specified dosing intervals. The findings of this pivotal study were shared at the European Academy of Dermatology and Venereology (EADV) event held in September 2024.

Pricing Strategy Aligned with Patient Needs

To further facilitate patient access, Celltrion has also implemented a strategic price reduction for YUFLYMA. Effective immediately, the wholesale acquisition cost for a syringe of YUFLYMA will be reduced to $948. This updated pricing not only resonates with the ongoing efforts to make medications more affordable but also shows Celltrion's dedication to improving healthcare outcomes for patients who rely on their products.

Since its introduction to the U.S. market in July 2023, YUFLYMA has swiftly gained acceptance in the healthcare community. It is available in various formulations, including prefilled syringes at doses of 20mg, 40mg, and 80mg, as well as autoinjectors for 40mg and 80mg. This variety is designed to cater to individual patient needs, promoting adherence to treatment regimens and maximizing therapeutic outcomes.

Commitment to Patients

Celltrion is determined to continue its leadership role in the biosimilar market, prioritizing patient needs and ensuring they have access to high-quality medications. The availability of YUFLYMA as an interchangeable treatment option alongside Humira offers healthcare professionals flexibility in managing patient care without compromising on quality or effectiveness.

As the pharmaceutical landscape evolves, Celltrion remains committed to innovating and advancing its products to meet the growing needs of patients and healthcare providers worldwide. Whether through strategic pricing initiatives or expanding product portfolios, Celltrion’s dedication to patient care remains at the forefront of their mission.

Conclusion

With the expanded FDA interchangeability designation, YUFLYMA stands as a testament to Celltrion's commitment to improving patient access and enhancing treatment affordability. This development not only underscores the importance of biosimilars in modern healthcare but also exemplifies Celltrion’s dedication to maintaining high standards in the pursuit of better patient outcomes.