First Off The Blocks, Fresenius Launches US Tocilizumab Biosimilar

Tyenne Version Is Approved In SC And IV Formulations; Rival Biogen Is Yet To Launch

Fresenius Kabi has kicked off competition to Genentech’s Actemra in the US, launching its Tyenne biosimilar version of tocilizumab.

Sprinters running off from starting blocks
Fresenius Kabi has been first to launch a US tocilizumab biosimilar • Source: Shutterstock

Fresenius Kabi has marked the start of US biosimilar competition to Actemra (tocilizumab), launching its Tyenne (tocilizumab-aazg) version in an intravenous formulation, which it said would provide “increased access and an affordable, high-quality, and safe treatment option for US patients.”

More from Products

Organon Looks To Tap Tocilizumab Potential Following Biogen Acquisition

 
• By 

Organon has swelled its immunology biosimilar portfolio after acquiring the US commercial rights to Bio-Thera’s tocilizumab biosimilar from Biogen, which last year decided to retain its interests in biosimilars following a lengthy strategic review.

Another One Bites The Dust: FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 

The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?

Teva Provigil ‘Pay For Delay’ Fines Should Stand, AG Says

 
• By 

Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.

Who’s Hired? Alvotech Appoints Strategy And Quality Chiefs

 
• By 

Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.

More from Generics Bulletin

Teva Provigil ‘Pay For Delay’ Fines Should Stand, AG Says

 
• By 

Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.

Who’s Hired? Alvotech Appoints Strategy And Quality Chiefs

 
• By 

Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.

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

 
• By 

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