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  • 12 Korean biosimilars globally approved in 3 months
  • by Chon, Seung-Hyun | translator Alice Kang | Mar 12, 2025 05:56am
The most amount of global approvals ever
Last year's record of 11 approvals was surpassed in just 3 months
8 biosimilar approvals for Celltrion and 4 for Samsung Bioepis in the U.S. and Europe
Celltrion totals at 24 approvals...Samsung Bioepis totals at 21 approvals
Domestic pharma and biotech companies have achieved 12 biosimilar approvals in the U.S. and Europe this year. Celltrion and Samsung Bioepis have surpassed last year's record of 11 approvals in three months due to their rapid global expansion. Together, Celltrion and Samsung Bioepis have received over 20 biosimilar approvals in Europe and the United States.

Celltrion received the U.S. Food and Drug Administration (FDA) approval for Xolair¡¯s biosimilar Omlyclo on the. 10, according to industry sources. Xolair is an antibody biologic drug used to treat allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic idiopathic urticaria. Xolair generated global sales of approximately KRW 6 trillion last year. Omly
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