Mylan Is First To Clear US Neulasta Biosimilar Hurdle; At-Risk Launch May Not Be Risky
Fulphila (pegfilgrastim-jmbd) to launch in US soon; Mylan overcomes complete response letter and gets approval without advisory committee review.
You may also be interested in...
Pfizer will aim to have its biosimilar Neulasta (pegfilgrastim) product, Nyvepria, on the market in both the EU and US by the end of the current quarter, a company spokesperson has informed Generics Bulletin, following a successful US launch.
The latest drug development news and highlights from our FDA Performance Tracker.
Mylan's Kokino spoke with Scrip about what he called the successful launch of the company's first biosimilar in the US, a version of Amgen's Neulasta, the state of the US biosimilar market and resetting expectations.