EMA to review Sandoz Neulasta biosimilar

The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) said EMA accepted an MAA for LA-EP2006, its proposed biosimilar of Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN), to treat chemotherapy-induced neutropenia. In November, FDA accepted for review a BLA for LA-EP2006, a pegylated granulocyte colony-stimulating factor (G-CSF) (see BioCentury Extra, Nov. 18, 2015).

Worldwide sales of Neulasta were $4.7 billion in 2015, including $824 million outside the U.S. ...