Celltrion announced on the 14th that it has obtained approval from the U.S. Food and Drug Administration (FDA) for the interchangeability change of its autoimmune disease treatment Yuflyma (ingredient name adalimumab) and the original medication Humira.
According to the U.S. interchangeability system, once this status is obtained, patients in the U.S. can receive bio similar (biologic drug copy) with the same efficacy and safety as the original medication at pharmacies without a doctor’s prescription. For corporations in the bio similar market, this can enhance their market influence.
The company explained, “Due to the characteristics of the U.S. prescription system, where prescriptions are issued based on the ingredient name rather than the product name, the interchangeability status can significantly impact the expansion of market share.”
Yuflyma, developed by Celltrion, is a high-concentration biosimilar of Humira. It is characterized by halving the drug dosage compared to the low concentration and removing citrate, which can cause pain. Currently, it is supplying three high-concentration products with capacities of 20mg/0.2ml, 40mg/0.4ml, and 80mg/0.8ml in the global market.
Based on global clinical trials conducted earlier involving 367 patients with moderate to severe plaque psoriasis, Celltrion applied for approval for the interchangeability change between Yuflyma and Humira.
The original medication Humira is an autoimmune therapy developed by the global pharmaceutical company AbbVie, which was approved in the U.S. in 2003. As of 2024, it recorded sales of approximately $8.993 billion (about 12.5902 trillion won), with U.S. sales accounting for about 79%.
A Celltrion official said, “With the recent approval of the Yuflyma interchangeability change, we have been able to further strengthen the product competitiveness of Yuflyma, which is showing steep growth in the U.S. market,” adding, “We will do our best to enhance the accessibility of Yuflyma in the U.S., the largest adalimumab market, and expand our market presence.”