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

Sandoz Gains An Edge With High-Concentration US Humira Biosimilar

Hyrimoz Version Of Adalimumab Approved By FDA In Citrate-Free 100mg/ml Form

 
• By Dave Wallace

Sandoz has gained a potential advantage ahead of being part of a second wave of Humira biosimilar competition hitting the US, with the firm obtaining FDA approval for its Hyrimoz version of adalimumab in a citrate-free high-concentration formulation.

High low 3D words
Sandoz now has FDA approval for both high and low strength adalimumab • Source: Shutterstock

With a second wave of Humira (adalimumab) rivals set to hit the US in just a few months time, Sandoz has gained US Food and Drug Administration approval for a citrate-free, high-concentration 100mg/ml version of its already approved Hyrimoz (adalimumab-adaz) biosimilar.

Following Amgen’s launch of its Amjevita (adalimumab-atto) 50mg/ml biosimilar at the end of January (Also see "Amgen Delivers On Launch Of First US Humira Rival – At A 55%...

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

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

 
• By Urtė Fultinavičiūtė

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.

Sandoz Leads Charge With First US Denosumab Launch

 
• By Dave Wallace

Competition to Amgen’s Prolia and Xgeva denosumab brands has hit the US market, with Sandoz taking the lead by launching its interchangeable Jubbonti and Wyost biosimilars.

‘Obsessive’ Teva Aims For $800m Biosimilar Sales By 2027

 
• By Dean Rudge

Teva says it is now in the “accelerate growth” phase of its strategic roadmap, with global biosimilar launches set to help the firm achieve its goals.

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.

More from Products

Sandoz Leads Charge With First US Denosumab Launch

 
• By Dave Wallace

Competition to Amgen’s Prolia and Xgeva denosumab brands has hit the US market, with Sandoz taking the lead by launching its interchangeable Jubbonti and Wyost biosimilars.

‘Obsessive’ Teva Aims For $800m Biosimilar Sales By 2027

 
• By Dean Rudge

Teva says it is now in the “accelerate growth” phase of its strategic roadmap, with global biosimilar launches set to help the firm achieve its goals.

Trump-Trimmed FDA Finally Releases A Batch Of PSGs – Back To Business As Usual?

 
• By Urtė Fultinavičiūtė

After half a year of silence, the US FDA has published 48 product-specific guidances for generic development. With critical staff laid off, will the health agency stick to its updated PSG publishing schedule?