2 K-biosimilars are approved in the US and Europe per year
By Chon, Seung-Hyun | translator Kim, Jung-Ju
23.05.31 06:17:32
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Samsung Bioepis’s Soliris biosimilar approved and becomes 7th approved in Europe
삼성바이오에피스는 2016년부터 미국서 5개 ·유럽서 6개 승인
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 Alex
Chon, Seung-Hyun(1000@dailypharm.com)
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