Alvotech And Teva File US Stelara Rival Ahead Of 2023 Expiry

Filing For AVT04 Proposed Ustekinumab Biosimilar Is Accepted By US FDA

Alvotech and marketing partner Teva have confirmed that their AVT04 proposed ustekinumab biosimilar rival to Stelara has been filed with the US FDA, ahead of a key patent expiry later this year.

Sign outside of FDA's headquarters in White Oak, MD
Alvotech’s Stelara biosimilar has been filed with the FDA • Source: Alamy

Alvotech and Teva have confirmed that their AVT04 proposed Stelara (ustekinumab) biosimilar has been accepted for filing by the US Food and Drug Administration, ahead of the blockbuster biologic brand’s US composition of matter patent expiring later this year.

More from Biosimilars

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.

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.

Richter Confirms European Tocilizumab Filing

Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.

Accord’s Denosumab Biosimilars Get Thumbs-Up From EMA

 
• By 

Accord received positive opinions for its Prolia and Xgeva biosimilars at the latest meeting of the EMA’s CHMP. Meanwhile, Celltrion picked up a nod for another Stelara biosimilar, while Rechon Life Science withdrew an application for human insulin.

More from Products

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.

Richter Confirms European Tocilizumab Filing

Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.