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  • 2 K-biosimilars are approved in the US and Europe per year
  • by Chon, Seung-Hyun | translator Kim, Jung-Ju | May 31, 2023 05:36am
13 Korean biosimilars approved in Europe, 10 in the US
Samsung Bioepis¡¯s Soliris biosimilar approved and becomes 7th approved in Europe »ï¼º¹ÙÀÌ¿À¿¡Çǽº´Â 2016³âºÎÅÍ ¹Ì±¹¼­ 5°³ ¡¤À¯·´¼­ 6°³ ½ÂÀÎ
Celltrion receives approval from 6 biosimilars in the U.S. since 2013
Celltrion, Samsung Bioepis each receive approval for 5 biosimilars in the U.S.
Biosimilar drugs that were developed in Korea are accelerating entry into the global market. Over the past decade, 13 and 10 biosimilars developed by Celltrion and Samsung Bioepis have been approved in Europe and the US, respectively. After Celltrion's Remsima received EMA approval in 2013, an average of 2 biosimilars have passed European and US review every year.

According to industry sources on the 31st, Samsung Bioepis has obtained approval from the European Commission (EC) for 'Epysqli', a biosimilar of the rare disease treatment 'Soliris.¡¯

Epysqli is the first biological drug developed by Samsung Bioepis in the field of hematology. Soliris is an ultra-high-priced drug developed by Alexion in the U.S. that is
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