Fresenius Delayed By FDA Inspection Uncertainty As It Works Towards US Pegfilgrastim Launch

Biosimilars Head Ali Ahmed Talks About Company’s Biosimilars Strategy

Ali Ahmed, senior vice president of biosimilars at Fresenius Kabi, considers the launch of the firm’s proposed Neulasta (pegfilgrastim) biosimilar in the US “an important milestone for the company.” However, he explains in an exclusive interview with Generics Bulletin, delays to necessary FDA inspections are creating uncertainty for the firm over launch timing.

Dealy
Ahmed said the upcoming pegfilgrastim launch was “an important milestone for the company” • Source: Fresenius Kabi

“Pegfilgrastim is not just another launch, this is our entry into the US biosimilars market,” stated Ali Ahmed, senior vice president of US biosimilars at Fresenius Kabi, talking about the company’s plan to launch its proposed Neulasta biosimilar in the US. In an exclusive interview, Ahmed told Generics Bulletin that “we engaged with a lot of key stakeholders and they're very excited for Fresenius Kabi to enter into the biosimilar market in the US.”

Calling the launch “an important milestone for the company,” Ahmed said that the company is now expecting US Food and...

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

More from Biosimilars

‘Our Position Has Naturally Shifted’ – How Standalone Sandoz Is Taking On Originator Abuses

 
• By 

As a standalone generics and biosimilars company, Sandoz now feels freer to speak out against originator abuses of intellectual property, the firm’s global IP head Julia Pike tells Generics Bulletin, including challenges to Bayer on rivaroxaban and Amgen on etanercept.

Kirsty Gives Biocon A First Interchangeable US Insulin Aspart Biosimilar

 
• By 

After years of waiting, Biocon Biologics has finally snagged US FDA approval for its insulin aspart biosimilar – along with a first designation of interchangeability. However, Sanofi’s Merilog version is already approved as a rival to Novo Nordisk’s Novolog.

Making The UK A Leading Biosimilar Launch Destination – Realistic Or Optimistic?

 

Experts discussed the UK government’s commitment to make the country a desirable destination for companies to launch their biosimilars at a recent conference hosted by Medicines UK.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By 

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

More from Products

MSN’s Entresto Generic Temporarily Blocked As Key US Patent Expires

 
• By 

The Federal Circuit has temporarily blocked MSN from launching a generic version of Entresto, granting Novartis short-term relief while it reviews the company’s emergency Rule 8 motion for a longer injunction.

Making The UK A Leading Biosimilar Launch Destination – Realistic Or Optimistic?

 

Experts discussed the UK government’s commitment to make the country a desirable destination for companies to launch their biosimilars at a recent conference hosted by Medicines UK.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By 

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.