1. Pink Sheet

Mylan Is First To Clear US Neulasta Biosimilar Hurdle; At-Risk Launch May Not Be Risky

 
• By Brenda Sandburg

Fulphila (pegfilgrastim-jmbd) to launch in US soon; Mylan overcomes complete response letter and gets approval without advisory committee review.

FDASignBldg21Entrance_1200x675

Mylan NV is set to launch Fulphila (pegfilgrastim-jmbd), the first biosimilar to Amgen Inc.'s Neulasta approved by the US FDA, "in the coming weeks" despite ongoing patent litigation with Amgen.

FDA approved the biosimilar on June 4 after Mylan and its partner Biocon Ltd. overcame regulatory hurdles that have...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Biosimilars

More from Biosimilars & Generics