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  • 11 years since global entry¡¦K-biosimilars
  • by Chon, Seung-Hyun | translator Kang, Shin-Kook | May 29, 2024 05:45am
received 15 European and 12 U.S. approvals
This year, Celltrion¡¤Samsung Bioepis received 3 approvals in Europe and the United States
Following the European approval of Remsima in 2013, Celltrion received 6 approvals in Europe and 5 approvals in the United States
Samsung Bioepis received the first European approval of Benepali in 2015¡¦received 6 approvals in Europe and 8 approvals in the United States
The biosimilar products developed by Korean companies are actively tapping into the global market. Celltrion received approval for Remsima in Europe in 2013. Since then, Koran companies have successfully commercialized 15 products in Europe and 12 products in the United States for the past 11 years. Celltrion secured 11 approvals in Europe and the United States, and Samsung Bioepis accomplished 14 approvals.

According to industry sources on May 27th, Celltrion and Samsung Bioepis¡¯ biosimilars received three approvals from Europe and the United States.

On May 24th, Celltrion received the European Commission (EC) approval for its Omlyclo, a biosimilar to Xolair. The official approval was granted in two months, aft
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