Years before Humira rivals hit the US market in 2023, a series of litigation settlements between biosimilar adalimumab developers and originator AbbVie provided a roadmap for a succession of date-certain launches this year. Now, similar settlements over Stelara between J&J and ustekinumab developers are starting to fall into place for 2025.
Until recently, biosimilars industry analysts had predicted that Johnson & Johnson’s immunology blockbuster Stelara (ustekinumab) could face US competition before the end of 2023, with the September expiry of a key patent protecting the top-selling brand.
However, recent developments have now upset those expectations, with a pair of separate settlements over ustekinumab biosimilars suggesting that the...
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.
