Celltrion Receives Approval for 20mg Yuflyma, Completing Full Dosage Lineup

Establishing a Comprehensive Dosage Lineup from Low-Weight Pediatric to Adult Patients

Enhanced Dosing Convenience with High-Concentration, Citrate-Free Formulations

Accelerating the Restructuring of the Global Adalimumab Market

Celltrion announced on March 5 that it has received product approval from the Ministry of Food and Drug Safety for the 20mg/0.2mL pre-filled syringe (PFS) formulation, a low-dose version of its autoimmune disease treatment 'Yuflyma' (ingredient: adalimumab).

With this approval, Yuflyma now offers a comprehensive high-concentration product lineup in three dosage strengths: 20mg, in addition to the existing 40mg and 80mg. In particular, the addition of the 20mg formulation enables more precise prescriptions for low-weight pediatric patients, expanding the range of options for healthcare professionals. Yuflyma is now available in all dosage ranges, from low to high, across all 12 previously approved indications, including rheumatoid arthritis, psoriasis, and pediatric Crohn's disease.

The entire Yuflyma lineup features a high-concentration formulation that eliminates citrate (citric acid salt), which can cause pain during injection, and halves the injection volume compared to lower concentrations. The company explained that its high-concentration technology minimizes the foreign body sensation felt during injection, thereby improving medication adherence among pediatric patients sensitive to pain or those who have an aversion to injections.

The original drug of Yuflyma, Humira, has seen its global sales volume shift from about KRW 12.6 trillion to KRW 6.4 trillion within just one year, accelerating the generational shift toward biosimilars. The company plans to rapidly capture the original drug’s market share following the completion of its full dosage lineup, while offering healthcare professionals a broader range of prescription choices and providing patients with optimal treatment options.

A Celltrion representative stated, "With this new 20mg approval, we have established an environment for 'tailored precision treatment' optimized for each patient, from low-weight pediatric patients to adults, here in Korea. We will absorb the demand shifting from the original drug and further expand our dominance in the autoimmune disease market."

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