1. Pink Sheet
  2. >>Biosimilars & Generics
  3. >>Biosimilars

Adello’s Filgrastim Biosimilar Faces Infringement Lawsuit And Potential Regulatory Delay

 
• By Sue Sutter

US FDA user fee date for privately held company’s 351(k) application referencing Amgen’s Neupogen may have passed without word of a regulatory action; Amgen sued Adello in March alleging infringement of 17 patents covering the innovator product.

Adello Biologics may be facing regulatory as well as legal hurdles in its bid to bring a proposed biosimilar of Amgen Inc.’s Neupogen (filgrastim) to the US market.

The user fee date for the company’s 351(k) application appears to have passed without public disclosure of an FDA regulatory action. For Adello, this suggests either a three-month user fee...

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

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.