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  • CHMP gave a positive opinion on the approval of Soliris
  • by Jung, Sae-Im | translator Kim, Jung-Ju | Apr 5, 2023 05:44am
European Advisory Committee (CHMP) affirms approval of Eculizumab
Official approval is expected after 2-3 months
Global Soliris market of about 5 trillion won, ¡°help to improve patient accessibility¡±
On the 31st of last month, Samsung Bioepis announced that it had obtained a positive opinion for the item approval of 'EPYSQLITM (Eculizumab)', a treatment for rare diseases, from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA). EPYSQLITM is a biosimilar of Alexion's paroxysmal nocturnal hemoglobinuria (PNH) treatment 'Soliris'. It is an expensive drug with annual treatment costs of hundreds of millions of won, and its annual global sales reached 3.762 billion dollars (approximately 4.7 trillion won) last year. EPYSQLITM is the first product developed by Samsung Bioepis in the field of hematology. It is expected that it will be able to obtain official sales permissio
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