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This undated imaged, provided by South Korean pharmaceutical giant Celltrion Inc., shows its biosimilar Yuflyma. (Celltrion Inc.) |
South Korean pharmaceutical giant Celltrion Inc. said Tuesday that a high-concentration version of its autoimmune disease biosimilar Yuflyma has won approval from European drug authorities.
The European Medicines Agency (EMA) gave the green light to Celltrion's application to sell Yuflyma -- a biosimilar referencing blockbuster drug Humira by AbbVie Inc.
The drug is used to treat patients with multiple chronic inflammatory diseases, such as rheumatoid arthritis and psoriasis, according to Celltrion.
The marketing authorization follows Celltrion's earlier approval from the EMA in Feb. 2021 for the lower-concentration version of Yuflyma.
The higher concentration-Yuflyma will be priced similarly to other biosimilars of Humira, potentially giving Celltrion an advantage in pricing and market access compared to the low concentration versions of biosimilars.
Yuflyma requires only half the solution administered to patients compared with the existing Humira biosimilar and is also citrate-free, which lessens discomfort during injection, Celltrion said.
The marketing authorization granted by the agency is valid in all European Union member states, as well as in the European Economic Area countries such as Iceland, Liechtenstein and Norway. (Yonhap)
