Sanofi Has EU Insulin Aspart Biosimilar Approval

Firm Comments on Pricing And Launch Plans For Rival To NovoRapid

Sanofi has received formal approval from the European Commission for its insulin aspart biosimilar.

Thumbs_Up_EU
The European Commission has formally approved Sanofi’s insulin aspart biosimilar • Source: Shutterstock

Sanofi has received formal European Commission approval granting a pan-European marketing authorization for its insulin aspart biosimilar.

The approval comes after the firm garnered a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for...

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

Xbrane Sets Date For Latest Run At Ranibizumab In US

 
• By 

After a series of setbacks for its Lucentis (ranibizumab) biosimilar filing in the US, Xbrane Biopharma now has a fresh action date from the FDA – although any approval will be contingent on a successful agency reinspection of its manufacturing sites.

Dr Reddy’s And Alvotech Team Up On Keytruda Rival

 
• By 

After previously partnering on denosumab, Alvotech and Dr Reddy’s have announced a further alliance to co-develop a biosimilar version of Keytruda (pembrolizumab).

The Generics Bulletin Podcast: The Global Generics & Biosimilars Awards 2025

 

With entries now open for the Global Generics & Biosimilars Awards 2025 – which takes place in Frankfurt on Wednesday 29 October – Generics Bulletin’s editors discuss all the key details, including tips for entrants, in our latest podcast.

UK-EU Deal ‘Must Include Medicines, Not Just Sausages,’ Urges Medicines UK

 

The UK struck three international agreements in May, but two of them failed to include medicines or provide any benefits for the pharmaceutical sector. Medicines UK warned that protecting medicine supplies should be of the same importance as defense.

More from Products

Shilpa Stumbles On Lenvima Challenge And Faces Wait Until 2036

 
• By 

Generic competition to Eisai’s oral-dose blockbuster cancer therapy Lenvima is set to materialize in the US in 2030 – however, for now, that won’t be from ANDA filer Shilpa Medicare.

The Generics Bulletin Podcast: The Global Generics & Biosimilars Awards 2025

 

With entries now open for the Global Generics & Biosimilars Awards 2025 – which takes place in Frankfurt on Wednesday 29 October – Generics Bulletin’s editors discuss all the key details, including tips for entrants, in our latest podcast.

Loss Of Exclusivity Product Launches To Fuel Aurobindo’s FY26 Europe Growth

 
• By 

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now