Fresenius Claims Edge With US Tocilizumab Biosimilar Approval

German Firm’s Tyenne Rival To Actemra Wins FDA Nod In Both IV And SC Presentations

Fresenius Kabi has claimed an advantage in the biosimilar tocilizumab arena after its Tyenne rival to Actemra was approved by the US FDA in both intravenous and subcutaneous formulations.

Two syringes with vials on white background
Tyenne has been approved in both IV And SC formulations • Source: Shutterstock

Fresenius Kabi has celebrated US approval for its Tyenne (tocilizumab-aazg) biosimilar rival to Actemra, noting that its version represented the “first tocilizumab biosimilar with an intravenous and subcutaneous formulation approved by the US Food and Drug Administration.”

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

More from Products

J&J Denied Injunction Over Private-Label Ustekinumab In US

 
• By 

Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.

UK Forxiga SPCs Wiped Out As Trio Succeed With Plausibility Attack

 
• By 

Generic competition to AstraZeneca’s blockbuster SGLT2 inhibitor Forxiga (dapagliflozin) treatment for diabetes may hit England and Wales earlier than 2028 after a pair of SPCs were invalidated following proceedings initiated by a trio of generics manufacturers.

What’s Next? Five Things To Look Out For In May

 
• By 

Generics Bulletin previews the most noteworthy and anticipated events for May 2025.