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.
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...
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.
Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains
Avoiding disaster at the beginning of the pandemic and offering a pro-active supply chain blueprint should position the generics industry well for an onshoring debate in Congress, but a look back at March 2020 is a reminder that even small policy shifts can have a big impact.
We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.
Teva and Biocon Biologics have become the latest firms to sign up to the Biosimilars Forum industry association in the US.
