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Celltrion launches ‘Uplyma 20mg’ for pediatric patients in the US… Customized prescription competitiveness↑

Uplaima 3 capacity lineup established
Easy to customize prescriptions for each patient… “Expected to increase local preference”
Autoimmune disease portfolio synergy in the world’s largest market

Celltrion Uplyma (40mg dosage form) product image. The actual product of Uplyma 20mg, which was launched in the U.S. market this time, has not yet been released.

Celltrion announced on the 28th that it has launched a 20mg dosage form of ‘Uplyma (ingredient name: adalimumab)’, a biosimilar for the treatment of autoimmune diseases, in the United States.

Uplyma 20mg is a high-concentration (100mg/mL) formulation that is the same as the 40mg and 80mg dosage formulations that were first introduced in the U.S. market. It was launched in the U.S. market as a prefilled syringe (PFS) product. It is said that the price was set at the same price as the existing dosage form, considering the competitiveness of Uplyma products and demand in medical settings. The 20 mg product will be used in pediatric patients.

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With the launch of this dosage form, Ulyma high-concentration products now have a total of three lineups. We expect that prescription preference and brand awareness will increase in the U.S. market as customized dosing becomes easier for a variety of needs, including new patients, patients requiring high-dose administration for each indication, and pediatric patients. It is expected to have a positive impact on strengthening overall product competitiveness.

Celltrion has completed a lineup of three autoimmune disease treatments in the U.S. market, including Uplyma, Inflectra (Remsima U.S. product name), and Zympentra (Infliximab subcutaneous injection formulation, domestic product name Remsima SC).

A Celltrion official said, “We attach great significance to the expansion of our autoimmune disease product portfolio through Uplaima. As we have established ourselves as a company that provides various prescription options to medical staff in the field of autoimmune diseases, we are expanding prescriptions through portfolio synergy.” “We expect this to accelerate,” he said.

In the case of Uplyma, it is also undergoing a change permit process to ensure interchangeability with the original product. Securing interchange status will enable more aggressive marketing as Euplaima can be prescribed at pharmacies without doctor intervention. It is expected that Uplaima’s competitiveness will be further strengthened in the future.

Humira, Uplaima’s original drug, is a global blockbuster drug with sales of approximately 27.6081 trillion won as of 2022. The world’s largest market is the United States, which is estimated to be worth about 24.2047 trillion won, or more than 87% of global sales.

A Celltrion official said, “We expect that the preference of medical staff for prescribing Uplaima will increase further as we have three dosage forms and can customize prescriptions according to patient cases.” He added, “We will actively utilize our product competitiveness in marketing to increase sales of Uplaima in the United States.” “We will expand,” he said.

Kim Min-beom, Donga.com reporter [email protected]

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