Alvotech And Teva Follow Amgen With US Stelara Settlement

Pair Gain 21 February 2025 Launch Date For AVT04 Ustekinumab Biosimilar

Teva and Alvotech have struck a deal with Stelara originator Johnson & Johnson to secure a 21 February 2025 launch date for their AVT04 ustekinumab biosimilar in the US – just over seven weeks after rival Amgen is able to enter the market.

Desk calendar showing February 2025
Teva and Alvotech have a launch date no later than 21 February 2025 • Source: Shutterstock

Alvotech and Teva have announced a settlement and licensing agreement with Johnson & Johnson that will allow Teva to launch the Alvotech-developed AVT04 proposed biosimilar to Stelara (ustekinumab) in the US “no later than 21 February 2025.”

While Teva and Alvotech’s proposed ustekinumab biosimilar is just one of many in development around the globe, AVT04 is one of only two Stelara rivals that has been confirmed to have been filed with the US Food and Drug Administration, with FDA review of the candidate expected to be complete in the second half of this year

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

Cutting Out The Middlemen? Trump’s Pricing Order Offers Opportunity On PBMs

 
• By 

Donald Trump’s executive order on most-favored-nation prescription drug pricing could provide positive opportunities for the off-patent industry, although US generics and biosimilars association the AAM suggested that the administration might do more good by focusing elsewhere.

Amneal Proud To Be ‘Made In America’ And Ready To Scale Up Its US Manufacturing

 

Amneal has set itself apart from competitors who are scrambling to find alternatives if proposed US pharmaceutical tariffs come into place. For the New Jersey-based firm, this is an opportunity to embrace its American identity and open a new chapter of growth.

‘I’ll Be Happy When We Have 40-Plus Assets’ – Sandoz Builds Up Biosimilars

 
• By 

With biosimilars playing an increasingly important role in Sandoz’s business, the firm’s first-quarter results call saw management lay out the latest key developments. Meanwhile, the company also addressed the issue of US tariffs, voicing optimism over both future developments as well as its ability to weather current measures.

Fresenius Kabi Lauds Tocilizumab Momentum As ‘Intense’ Transfer To mAbxience Continues

 
• By 

Fresenius Kabi continued to reap the rewards of its fledgling commercial Biopharma business in the first quarter, as the firm eyes further growth for its tocilizumab biosimilar in the US and Europe in the second half of 2025.

More from Products