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  • K-similars won record number of U.S.¡¤Europe nods this year
  • by Chon, Seung-Hyun | translator Kang, Shin-Kook | Aug 27, 2024 05:50am
'30 approvals over 11 years'
Celltrion¡¤Samsung Bioepis won 6 approvals this year¡¦exceeding the previous 5 approvals in 2019
For 11 years, 30 products have been approved since Remsima launched in Europe in 2013¡¦averaging 3 per year
Celltrion won 14 U.S.¡¤Europe nods¡¦Samsung Bioepis won 16 approvals
Korean biopharmaceutical companies have launched the highest number of biosimilars in history this year in the United States and European markets. As Celltrion and Samsung Bioepis won approvals for six biosimilars over eight months in the world's largest market, they topped the previous record of five cases of five years ago.

According to sources on August 27th, Celltrion's SteQyma, a biosimilar to Stelara for the treatment of autoimmune diseases, received marketing authorization from the European Commission (EC). It reached the final commercialization step two months after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency's (EMA) committee issued a positive opinion recommendin
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