1. Generics Bulletin
  2. >>Products
  3. >>Biosimilars

Accord Follows US Approval With EU Nod On Ustekinumab

Two Versions Of Stelara Biosimilar Approved As Absimky And Imuldosa

 
• By Dave Wallace

Accord has received a nod from the EMA for its Stelara biosimilar, while Neuraxpharm has seen a buprenorphine hybrid film endorsed and Viatris has received a positive CHMP opinion for an eltrombopag generic.

The CHMP endorsed several new products at its October meeting (Shutterstock)

The latest meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use has resulted in positive opinions for Accord Healthcare’s Stelara (ustekinumab) biosimilar as well as a buprenorphine hybrid film for Neuraxpharm and an eltrombopag generic for Viatris.

While CHMP positive opinions do not constitute formal approval, the European Commission typically acts within 67 days to convert them...

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 Biosimilars

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

 
• By Dave Wallace

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 Dave Wallace

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

 
• By Urtė Fultinavičiūtė

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 Dave Wallace

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

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

 
• By Dean Rudge

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.

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

 
• By Dave Wallace

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.

US Federal Circuit Clears Path for MSN to Market Entresto Generic

 
• By Dean Rudge

Novartis has failed to secure a court order to stop MSN from launching a generic Entresto, and has also seen an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.