1. Generics Bulletin
  3. >>Regulation

Biocon And Mylan Prime Pegfilgrastim Expansion

US FDA Approves Biocon’s sBLA for New Pegfilgrastim Facility

 
• By Anju Ghangurde

Biocon-Mylan’s sBLA for pegfilgrastim made at a new Indian site gets an FDA go-ahead, facilitating a "multi-fold" scale up in capacity. But it will be interesting to watch how impactful this could be on market dynamics in the US, where more competition has arrived.

Warehouse_Worker
Biocon And Mylan Build Additional Capacity For Fulphila • Source: Shutterstock

Biocon Ltd. and partner Mylan NV expect expanded manufacturing capacity for pegfilgrastim to address growing market opportunities in the US for Fulphila (pegfilgrastim-jmdb), their biosimilar rival to Amgen Inc.’s Neulasta reference biologic, amid the recent entry of more competition.

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 Regulation

More from Policy & Regulation