Teva setback as second 'biosimilar' Neulasta BLA withdrawn
This article was originally published in Scrip
Executive Summary
Teva says that it has withdrawn the biologics license application (BLA) for balugrastim, a long-acting granulocyte colony-stimulating factor (G-CSF), following a request by the US FDA for "additional confirmatory data". Teva's biosimilar G-CSF program has long been a concern for Amgen, which markets the blockbusters products Neupogen (filgrastim, a short-acting G-CSF) and Neulasta (pegfilgrastim, a long-acting G-CSF).