Celltrion said Oct. 20 that it has strengthened the competitiveness of its autoimmune therapy Yuflyma (active ingredient: adalimumab) after receiving additional pediatric indications from the U.S. Food and Drug Administration.
The newly approved pediatric indications cover juvenile uveitis and hidradenitis suppurativa. Celltrion obtained the approvals to align with the expiration of the originator product’s exclusivity, positioning the company for rapid entry and share gains in the related markets.
The expanded labeling gives pediatric patients—who historically had limited treatment options—access to Yuflyma at a more affordable price while providing treatment benefits equivalent to the originator product, the company said.
Celltrion plans to leverage the strengthened product profile to accelerate market share growth for Yuflyma in the U.S., the world’s largest drug market. The company is expanding distribution channels and building sales routes in the U.S., using a dual-pricing strategy for the product.
Recently, the FDA granted an interchangeability designation for Yuflyma with the originator Humira, further increasing confidence in cross-prescribing. With pharmacies now able to substitute Yuflyma for the originator based on equivalent efficacy and safety, Celltrion expects the designation to have a significant positive impact on sales.
Yuflyma is a high-concentration biosimilar of Humira that halves the administered volume compared with lower-concentration formulations and removes citrate, a component that can cause injection pain. Celltrion currently supplies a global high-concentration lineup in three strengths: 20 mg/0.2 mL, 40 mg/0.4 mL and 80 mg/0.8 mL.
Humira, the originator adalimumab, was a global blockbuster with approximately $8.993 billion in sales in 2024, of which more than 79%—about $7.142 billion—came from the U.S.
A Celltrion spokesperson said the new pediatric approvals are expected to increase prescriptions for pediatric patients in the U.S. and that timing the approval with the originator’s exclusivity expiry will enable rapid market entry. The company added it will push to solidify its position and expand sales in the U.S. adalimumab market.
