Settlement agreements reached by Humira biosimilar chasers Amgen, Samsung Bioepis and Sandoz in 2017 and 2018 were challenged in court by adalimumab purchasers, which alleged they formed were a part of a broader scheme to hold up competition to the multi-billion-dollar blockbuster brand in the US. But the biosimilar firms and AbbVie will not have to face the antitrust claims.
Patent-litigation settlements agreed by biosimilar sponsors Amgen, Samsung Bioepis and Sandoz that played a part in AbbVie maintaining control over the market for Humira (adalimumab) in the US do not amount to violations of antitrust regulations, a US district court has held.
Illinois district judge Manish Shah dismissed both federal and state claims brought by a class of indirect Humira purchasers, including...
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.
