On May 27, 2025, Fresenius Kabi (“Fresenius”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Fresenius’s two denosumab biosimilar candidates....more
In a case that raises important issues of perhaps Constitutional dimensions (at least in Circuit Court Judge Newman's view), the Biotechnology Industry Organization (BIO) urged the Federal Circuit to rehear the panel decision...more