Celltrion Secures Additional Pediatric Indications for Uplyma in the U.S.

Securing Additional Competitiveness in the Market
Accelerating Entry into the $10 Billion Market

Celltrion has accelerated its efforts to penetrate the US market by obtaining additional approval from the US Food and Drug Administration (FDA) for pediatric indications of its autoimmune disease treatment drug, Uplyma (ingredient name: adalimumab).

Celltrion's autoimmune disease treatment drug Uplyma. Celltrion

According to Celltrion on October 20, the newly approved indications for Uplyma are pediatric uveitis and hidradenitis suppurativa. These segments represent markets that open up as the exclusivity period for the original drug (AbbVie's Humira) expires, allowing for immediate sales expansion upon approval and providing an "early entry effect." Pediatric patients, who previously had limited treatment options, can now benefit from Uplyma as an alternative at a more reasonable price while receiving the same therapeutic benefits as the original drug.

Celltrion plans to leverage its enhanced product competitiveness to increase Uplyma's market share in the United States, the world's largest pharmaceutical market. The company is also accelerating the expansion of its distribution channels in the US, utilizing a dual pricing strategy for Uplyma to build out its sales network.

Recently, Celltrion received FDA approval for interchangeability between Uplyma and the original drug, Humira, further increasing confidence in cross-prescribing. As pharmacies can now prescribe Uplyma based on its equivalent efficacy and safety compared to the original drug, significant sales growth is expected.

The US biosimilar market has seen intense competition among Humira biosimilars since 2023, with nine adalimumab-based products currently competing. However, few products combine high-concentration formulations and interchangeability. This is where Uplyma stands out. Compared to the conventional low-concentration version, the high-concentration formulation halves the injection volume and removes citrate, which causes pain, thereby improving medication convenience and adherence. Celltrion currently supplies a global lineup of high-concentration products in three dosages: 20mg/0.2ml, 40mg/0.4ml, and 80mg/0.8ml.

The original drug for Uplyma, Humira, recorded global blockbuster sales of approximately $8.993 billion (about 12.5902 trillion won) last year. Of this, more than 79%-about $7.142 billion (about 9.9988 trillion won)-was generated in the United States, the world's largest pharmaceutical market. Although the newly secured market segment is relatively small, it is considered a market with a strong "lock-in effect" for prescription patterns. In the US, prescriptions for autoimmune disease treatments begin in childhood and adolescence, leading to a high proportion of long-term use, and brand loyalty often continues into adulthood.

A Celltrion representative stated, "With the addition of pediatric indications for Uplyma, new treatment options will be available for pediatric patients in the US, and we expect an increase in prescriptions in clinical settings. As this approval coincides with the expiration of the original drug's exclusivity for these indications, we anticipate rapid market entry and plan to further strengthen our position and accelerate sales growth in the US adalimumab market."

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