1. Generics Bulletin
  2. >>Archive

Mylan and Biocon have first pegfilgrastim in US

Mylan has received approval from the US Food and Drug Administration (FDA) for the first biosimilar of Amgen’s Neulasta (pegfilgrastim) in the US, with the Fulphila (pegfilgrastim-jmdb) 6mg/0.6ml injectable biosimilar co-developed with Biocon. Expected to be “the first biosimilar pegfilgrastim available in the US”, Fulphila is set to be launched “in the coming weeks”, Mylan anticipates, with a “suite of patient services” to further support patients and caregivers with treatment.

Mylan has received approval from the US Food and Drug Administration (FDA) for the first biosimilar of Amgen’s Neulasta (pegfilgrastim) in the US, with the Fulphila (pegfilgrastim-jmdb) 6mg/0.6ml injectable biosimilar co-developed with Biocon. Expected to be “the first biosimilar pegfilgrastim available in the US”, Fulphila is set to be launched “in the coming weeks”, Mylan anticipates, with a “suite of patient services” to further support patients and caregivers with treatment.

FDA approval was based on review of evidence that included “extensive structural and functional characterisation, animal study data, human pharmacokinetic...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin 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 Archive

More from Generics Bulletin

Stelara Biosimilar Sees Stada’s Specialty Sales Start Strong In Q1

 
• By Dave Wallace

Stada’s Specialty division was boosted by the firm’s launch last year of a European Stelara biosimilar, even as generics growth remained muted in Q1.

Formycon Snatches First Brazilian Approval For Lucentis Biosimilar

 
• By Urtė Fultinavičiūtė

Formycon is preparing to start a new era – entering Latin America with its ranibizumab biosimilar, which is expected to be a “good contributor” to the firm’s finances.

Corapharm Deal Offers South-East Europe Opportunity For mAbxience

 
• By Dave Wallace

Hot on the heels of a recent alliance in Italy, biosimilars developer mAbxience has struck another deal – this time partnering with Corapharm in south-east Europe.