Securing Interchangeability Status
Accelerating Entry into the Largest U.S. Market
Celltrion recently announced on the 14th that it has obtained approval from the U.S. Food and Drug Administration (FDA) for the interchangeability designation between its autoimmune disease treatment Uplyma (generic name: adalimumab) and the original drug Humira.
The U.S. interchangeability system allows biosimilar drugs with the same efficacy and safety to be substituted for the original drug. Once granted interchangeability status, patients can receive the biosimilar with the same efficacy at pharmacies without a doctor’s prescription instead of the original drug.
Celltrion previously applied for approval of the interchangeability designation between Uplyma and Humira based on a global clinical trial involving 367 patients with moderate to severe plaque psoriasis.
With this approval, Uplyma is expected to enhance user confidence in cross-prescription by securing interchangeability status in the U.S. Due to the U.S. prescription system where prescriptions are issued by generic name rather than product name, interchangeability status can significantly impact market share expansion.
Uplyma, developed by Celltrion, is a high-concentration biosimilar of Humira, characterized by reducing the drug dosage to half compared to the low concentration version and removing citrate, which can cause pain. Currently, it is supplied globally in three high-concentration product lineups: 20 mg/0.2 ml, 40 mg/0.4 ml, and 80 mg/0.8 ml.
In particular, Uplyma is increasing its market share in major European countries through customized bidding strategies, and is accelerating its market expansion in the U.S. by expanding distribution channels based on a dual pricing policy, resulting in a gradually faster global sales growth rate.
The original drug Humira, of which Uplyma is a biosimilar, recorded global blockbuster sales of approximately $8.993 billion (about 12.5902 trillion KRW) in 2024. Of this, more than 79% of total sales, about $7.142 billion (about 9.9988 trillion KRW), were recorded in the United States, the world’s largest pharmaceutical market.
A Celltrion official stated, "With the approval of Uplyma’s interchangeability designation, we can further strengthen the product competitiveness of Uplyma, which is showing rapid growth in the U.S. market. We will do our best to increase Uplyma’s accessibility in the U.S., the world’s largest adalimumab market, and expand its position in the market."
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