Celltrion's YUFLYMA® Receives FDA's Interchangeable Designation to Humira®

Introduction


In a significant advancement for patient care, Celltrion, Inc. has announced that the U.S. Food and Drug Administration (FDA) has officially designated YUFLYMA® (adalimumab-aaty) as an interchangeable biosimilar to Humira® (adalimumab). This groundbreaking classification not only represents a major milestone for the innovative biopharmaceutical company but also promises to enhance accessibility of treatments for patients suffering from a variety of inflammatory conditions.

What is YUFLYMA®?


YUFLYMA® is a high-concentration formulation (100 mg/mL) of adalimumab, which has been specially designed to be citrate-free. This allows practitioners to provide effective treatment without the discomfort associated with citrate in injections. With its approval for multiple inflammatory conditions including rheumatoid arthritis, plaque psoriasis, and Crohn's disease, YUFLYMA® emerges as a robust alternative to Humira®.

Celltrion's Chief Commercial Officer, Thomas Nusbickel, expressed enthusiasm about the designation, stating that it positions YUFLYMA to improve patient access to necessary therapies effectively. Patients will benefit from the seamless transition to YUFLYMA, as it shares the same dosing regimen, administration route, and dosage form as Humira. This interchangeability can potentially simplify the medication switch process right at the pharmacy, making it easier for patients without the need for additional prescriptions or learning new administration methods.

The Importance of the Interchangeability Designation


The interchangeable designation is significant because it allows pharmacists to substitute YUFLYMA for the reference product, Humira, without needing prescriptive authorization from the healthcare provider. This change can relieve patients from administrative burdens and enhance their access to antibacterial treatments.

The FDA's endorsement of this designation stems from positive data acquired from a Phase III interchangeability study involving patients with moderate to severe plaque psoriasis. The study determined that patients switching between YUFLYMA and reference adalimumab exhibited comparable pharmacokinetics, efficacy, safety, and immunogenicity. Results were shared at the European Academy of Dermatology and Venereology (EADV) conference in 2024, further bolstering the case for interchangeable biosimilars in general.

Accessibility and Pricing


Another key point of interest is the pricing model that accompanies YUFLYMA®. Patients can access the non-branded version, adalimumab-aaty, at an impressive 85% discount compared to Humira's wholesale acquisition cost (WAC). This pricing strategy aims to foster financial relief for patients while simultaneously providing significant economic benefits to the healthcare system. The branded version offers a more modest 5% discount off the WAC of Humira.

In May 2023, the FDA had already given a nod of approval for the high-concentration formula of YUFLYMA®, which became available in the U.S. market as of July 2, 2023. The product is currently offered in several forms, including prefilled syringes and autoinjector pens, with 20 mg, 40 mg, and 80 mg solutions available.

Conclusion


Overall, the FDA's grant of the interchangeable designation for YUFLYMA® marks a pivotal moment in the biosimilars landscape, potentially revolutionizing patient access to crucial therapies. With increased affordability and straightforward substitutions at pharmacies, YUFLYMA® enhances the treatment options available to patients battling severe inflammatory conditions. As further developments in the field of biosimilars continue to evolve, Celltrion remains committed to delivering innovative life-enhancing therapies that address critical patient needs. For more information on YUFLYMA® and its offerings, visit Celltrion's official website.

Topics Health)

【About Using Articles】

You can freely use the title and article content by linking to the page where the article is posted.
※ Images cannot be used.

【About Links】

Links are free to use.