Celltrion has launched the 20 mg dosage form of its biosimilar Yuflyma (adalimumab-aaty) for treating autoimmune diseases in the United States.
Yuflyma 20 mg shares the same high-concentration (100 mg/mL) formulation as the 40 mg version launched in the U.S. last year and the 80 mg version launched in January of this year. It is available in a prefilled syringe (PFS).
The price of Yuflyma 20 mg remains unchanged from the existing dosage forms, considering the competitiveness of the product and the requirements of healthcare providers.
Yuflyma 20 mg is designed for use in pediatric patients. The expansion of Yuflyma's high-concentration product lineup to three dosage forms in the U.S. is expected to enhance Yuflyma's appeal for prescribing by allowing customized dosing for various specific needs, including new patients, those requiring high doses for specific indications, and pediatric patients.
In addition to Inflectra (known as Remsima in the U.S.), currently marketed by Celltrion in the U.S., Zymfentra (Remsima SC in the U.S.), the world's only infliximab subcutaneous formulation, was launched in the U.S. on March 15, bringing the total number of Celltrion's autoimmune disease treatments to three.
Yuflyma's reference drug, Humira, is projected to generate approximately $21.237 billion in sales by 2022, with the U.S. accounting for approximately $18.619 billion, or more than 87% of total sales.
"The introduction of Yuflyma 20 mg will offer pediatric patients with autoimmune diseases in the U.S. more flexible options and convenient self-administration," said an official from Celltrion. "We anticipate that having three dosage forms will further increase healthcare providers' preference for prescribing Yuflyma by allowing tailored prescribing based on individual patient cases."
