Celltrion Launches Pediatric Version of 'Uplima' in the US

Celltrion announced on the 28th that it has launched a 20mg dosage formulation of the biosimilar Uplyma for pediatric patients in the United States.

Celltrion's biosimilar for autoimmune disease treatment, 'Uplima'
[Photo by Celltrion]

Uplyma 20mg is a high-concentration formulation of 100mg/mL, identical to the 40mg and 80mg products released in the US last year and this January. It was launched as a prefilled syringe (PFS) product ready for immediate injection. The wholesale price was set at $6,576.5 for two doses, the same as the existing 40mg and 80mg dosage formulations.

The newly launched Uplyma 20mg is intended for use in pediatric patients. With the expansion of Uplyma’s high-concentration product lineup to a total of three dosage formulations, it is expected that tailored dosing will be possible for various cases, including new patients, patients requiring high-dose administration by indication, and pediatric patients.

Celltrion currently has three autoimmune disease treatment products in the US market: Inflectra (the US product name for Remsima), which is already being sold; Uplyma, launched last year; and Zimpentra (the US product name for RemsimaSC), a new drug launched on the 15th (local time) that converts Remsima into a subcutaneous injection formulation for easier administration. It is expected that portfolio synergy will accelerate prescription expansion through these three autoimmune disease treatment products.

Humira, the original drug of Uplyma developed by AbbVie, is a global blockbuster product that recorded sales of $14.44 billion (approximately 19 trillion KRW) last year. However, this was due to a decline in Humira’s sales following the launch of biosimilars and AbbVie’s price reductions to overcome this, as sales reached $21.237 billion (approximately 28.6275 trillion KRW) in 2022, indicating that the actual market size is larger.

A Celltrion official stated, “With the launch of the Uplyma 20mg dosage formulation, we can provide more flexible options and convenient self-administration opportunities to pediatric patients with autoimmune diseases in the US. Having three dosage formulations allows for customized prescriptions based on patient cases, which is expected to increase healthcare providers’ preference for prescribing Uplyma. We will actively utilize this product competitiveness in marketing to expand Uplyma’s sales in the US.”