Celltrion Receives FDA Approval for 10mg Dosage Form of Yuflyma in the U.S.

Accelerating Entry into the Global Adalimumab Market
with Enhanced Product Competitiveness

Celltrion announced on November 3 that it has received additional approval from the U.S. Food and Drug Administration (FDA) for the 10mg/0.1ml (10mg) dosage form of its autoimmune disease treatment, Yuflyma (ingredient name: adalimumab).

Celltrion

This 10mg dosage form has been approved as a pre-filled syringe (PFS) formulation, enabling personalized prescriptions for pediatric patients with juvenile idiopathic arthritis (JIA) who weigh at least 10kg but less than 15kg.

With this additional approval, Celltrion now offers a complete lineup of four high-concentration dosage forms currently prescribed in the U.S. market: 10mg/0.1ml, 20mg/0.2ml, 40mg/0.4ml, and 80mg/0.8ml. This allows for tailored dosing according to patient condition and indication, which is expected to further increase the prescription preference for Yuflyma in the adalimumab market. In particular, as Yuflyma's global sales are growing rapidly, the addition of the 10mg/0.1ml dosage form in the U.S. is expected to drive further sales growth by expanding the patient base.

Since the launch of Yuflyma in the U.S., the company has been making continuous efforts to strengthen its market position not only through dosage expansion but also by broadening indications. Recently, Celltrion received FDA approval for interchangeability between Yuflyma and the original drug Humira, further boosting confidence in prescriptions. The company has also obtained additional pediatric indications, working to expand treatment areas and increase prescription favorability.

Developed by Celltrion, Yuflyma is a high-concentration biosimilar of Humira. It reduces the drug administration volume by half compared to the low-concentration version and is formulated without citrate, which can cause pain.

The original drug, Humira, recorded global sales of approximately $8.993 billion (about 12.59 trillion won) as of 2024, making it a blockbuster product. Of this, more than 79%-about $7.142 billion (about 9.999 trillion won)-was generated in the U.S., the world’s largest pharmaceutical market.

A Celltrion official stated, "With the additional approval of the 10mg dosage form of Yuflyma, we can now offer a new treatment option for pediatric patients with autoimmune diseases in the U.S. Having secured a full lineup of high-concentration products in the market, we are now able to provide personalized prescriptions tailored to various patient cases. We will do our utmost to expand our market share in the U.S. based on our product competitiveness."

This content was produced with the assistance of AI translation services.