Samsung Snags Second Soliris Biosimilar In US
Following Amgen’s Earlier Nod, Samsung Bioepis Gets FDA Approval For Eculizumab
Executive Summary
Samsung Bioepis has received US FDA approval for its Epysqli eculizumab biosimilar to Soliris, only the second version to be authorized in the US. However, the company declined to comment on launch plans as litigation with originator Alexion remains ongoing.