Alvotech’s Denosumab Biosimilar Takes Steps Forward With EMA Filing Acceptance

Regulatory Submissions For AVT03 In Other Major Global Markets Are Expected ‘Soon’

Alvotech is the latest to join several other competitors who have already submitted their denosumab biosimilar marketing authorization applications to the EMA.

Figure walking over blocks representing goals towards a flag finish
(Shutterstock)

First one in the bag. The European Medicines Agency has accepted Alvotech’s marketing authorization application for its AVT03, a denosumab rival to Amgen’s Prolia/Xgeva brands, for review.

“EMA acceptance marks an important step towards making AVT03 available to patients and caregivers in Europe,” said Alvotech’s chief scientific...

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

The Generics Bulletin Top 50, Part One: German Giants Rise Up The Ranks

 
• By 

Two leading German generics and biosimilars giants were the big movers in our top ten ranking of off-patent industry leaders for 2025. We reveal the latest developments among the top players in the first instalment of this year’s Generics Bulletin Top 50.

Just One Week To Go! Entry Deadline Looms For GGB Awards 2025

 
• By 

There is now just one week left to submit entries to the Global Generics & Biosimilars Awards 2025, with the entry deadline set for August 1.

Biocon Biologics ‘Strategically’ Expands Enbrel Biosimilar With A Launch In Australia

 

After acquiring a solid biosimilars business from Viatris, Biocon Biologics has ticked off another market for its Nepexto (etanercept).

‘Europe Has To Make Up Its Mind’ – Medicines For Europe’s Sieger On The Path Ahead

 
• By 

At an eventful time for the European generics and biosimilars industry, Medicines for Europe interim president and Polpharma CEO Markus Sieger talks about what the European healthcare sector needs and what the off-patent sector can deliver.

More from Generics Bulletin

Sun Strikes Further US Price-Fixing Settlement For $200m

 
• By 

The latest development in the long-running US generic price-fixing saga has seen Sun Pharma agree a $200m settlement in connection with an end purchaser action in Pennsylvania.

Just One Week To Go! Entry Deadline Looms For GGB Awards 2025

 
• By 

There is now just one week left to submit entries to the Global Generics & Biosimilars Awards 2025, with the entry deadline set for August 1.

UK Xtandi Patent Stands Strong As Accord, Sandoz, Teva Lose Appeal

 
• By 

The Court of Appeal in London has upheld a key UK patent shielding Astellas’ Xtandi, rejecting claims by a trio of generic drugmakers that it was obvious after finding that the generics firms’ expert analysis was tainted by hindsight.