On August 30, 2024, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) and Samsung Bioepis Co. Ltd. (“Samsung Bioepis”) settled their BPCIA dispute related to...more
The Biden Administration recently released a 2025 Budget Proposal which includes permitting biosimilar substitution without the Food and Drug Administration’s (“FDA”) separate determination of interchangeability. ...more