#South Korea #Incheon #Celltrion #Humira #YUFLYMA

Celltrion's YUFLYMA® Achieves Full Interchangeability Designation

On May 23, 2025, Celltrion, Inc., based in Incheon, South Korea, made an important announcement regarding its biosimilar product YUFLYMA® (adalimumab-aaty). The U.S. Food and Drug Administration (FDA) has granted YUFLYMA an expanded interchangeability designation, which now includes prefilled syringes of 40mg and autoinjectors in 40mg and 80mg presentations. This is a significant milestone for Celltrion as it positions YUFLYMA to compete more effectively against the reference product, Humira® (adalimumab), across all approved dosage forms and strengths.

YUFLYMA is a high-dose, citrate-free formulation designed to treat a range of inflammatory diseases. It has been approved for conditions such as rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), ulcerative colitis (UC), plaque psoriasis (Ps), hidradenitis suppurativa (HS), and uveitis (UV) in adults, as well as Crohn's disease (CD) in both adult and pediatric patients over six years old. Notably, it also addresses juvenile idiopathic arthritis (JIA) for children aged two and older.

Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, remarked, "This full interchangeability designation comes at a pivotal time as Celltrion continues to lead in the evolving biosimilar landscape. YUFLYMA reflects our long-standing commitment to delivering affordable, high-quality treatment options to patients."

The FDA's decision was informed by the outcomes of a Phase III interchangeability study that demonstrated comparable pharmacokinetics, safety, efficacy, and immunogenicity between patients using reference adalimumab continuously and those alternating between reference adalimumab and YUFLYMA. These findings were shared at a prestigious dermatology conference, marking a crucial point for the biosimilar’s acceptance within the medical community.

Since its introduction to the U.S. market in July 2023, YUFLYMA has been available in various forms, including 20mg, 40mg, and 80mg solutions for injection in prefilled syringes and as autoinjectors in 40mg and 80mg doses. Celltrion's strategy includes offering both branded and unbranded versions of adalimumab-aaty to enhance affordability and access, catering to diverse patient needs.

Furthermore, YUFLYMA distinguishes itself with one of the longest shelf lives in its class, ensuring stability at room temperature (77°F, 25°C) for up to 31 days. While the recent years have seen a surge in the development of biosimilars, Celltrion’s focus on maintaining quality and cost-effectiveness positions it as a pillar in the pharmaceutical landscape.

As the demand for biologic treatments continues to grow, YUFLYMA's expanded interchangeability could redefine treatment accessibility, providing patients with various options without compromising quality. Celltrion plans to capitalize on this momentum by ensuring competitive pricing and expanding the potential patient base.

This FDA designation not only reflects the evolving biosimilar market but also highlights Celltrion's commitment to advancing therapies that improve the quality of life for patients facing serious and chronic health challenges. For more information about YUFLYMA or its comprehensive product line, you can visit Celltrion's official website.

Important Safety Considerations

While YUFLYMA presents an exciting option for patients, it is crucial to understand the associated risks, including increased susceptibility to infections, malignancy risks, and hypersensitivity reactions. Patients and healthcare providers should conduct thorough evaluations before initiating therapy, especially for those with existing health conditions or those receiving immunosuppressive therapies.

In summary, Celltrion’s recent developments with YUFLYMA mark a transformative step in the industry, elevating the standard of care for a wide array of inflammatory conditions and bolstering patients' access to necessary treatments.