Samsung Bioepis’ Epysqli Is the Second Eculizumab Biosimilar Approved by the FDA

On July 22, Samsung Bioepis announced that it has received marketing approval by the FDA for its eculizumab biosimilar Epysqli®. The vowel-challenged brand name, which also has an interesting nonproprietary suffix (eculizumab-aagh), is the second approved biosimilar for the reference product Solaris®. The approval for this C5 complement protein inhibitor covers the following indications: Samsung … Continue reading Samsung Bioepis’ Epysqli Is the Second Eculizumab Biosimilar Approved by the FDA