Approval of 10mg dosage for pediatric patients… Completion of high-concentration 4-product lineup Targeting the world's largest U.S. market, valued at approximately KRW 10 trillion Expecting market share expansion through increased prescription preference Simultaneous pursuit of original interchangeability and additional indications
Celltrion's Third Plant
Celltrion announced on the 3rd that it has obtained additional approval from the U.S. Food and Drug Administration (FDA) for the 10mg/0.1ml dosage form of the autoimmune disease treatment 'Yuflyma' (ingredient name: adalimumab).
This 10mg dosage has been approved in a pre-filled syringe (PFS) form. It can be prescribed for pediatric patients with juvenile idiopathic arthritis (JIA) who weigh between 10kg and less than 15kg. With the addition of this new dosage, Celltrion now offers a total of four high-concentration dosage lineups in the U.S. market, including 20mg/0.2ml, 40mg/0.4ml, and 80mg/0.8ml. This allows for more precise, tailored dosing based on the patient's condition or indication, which is expected to increase product prescription preference in the future. Notably, Yuflyma's global sales are rapidly growing, which is anticipated to positively impact Celltrion's overall performance.
Celltrion emphasized that, following the launch of Yuflyma in the U.S., it is also pursuing an expansion of indications in addition to dosage expansion. As part of this effort, it recently secured FDA approval for interchangeability between Yuflyma and the original product (Humira). Additionally, it is focusing on expanding treatment areas and improving prescription preference by adding pediatric indication approvals.
Celltrion Yuflyma
Celltrion Yuflyma is a high-concentration Humira biosimilar product that reduces the drug dosage by half compared to low-concentration versions and removes citrate, which can cause pain.
The original Humira is a blockbuster drug with global sales reaching approximately KRW 12.5902 trillion last year. Of this, about 79% (approximately KRW 9.9988 trillion) was generated in the U.S. market.
A Celltrion representative stated, "With the additional approval of Yuflyma's dosage form, we can offer a new treatment option for pediatric patients with autoimmune diseases in the U.S. By securing a complete lineup of high-concentration products in the market, we have gained competitive advantage for tailored prescriptions based on various patient cases, and we will strive to expand our market share in the world's largest market, the U.S."
Kim Min-beom
AI-translated with ChatGPT. Provided as is; original Korean text prevails.
ⓒ dongA.com. All rights reserved. Reproduction, redistribution, or use for AI training prohibited.
