The pool of prospective Xolair biosimilars is small, with only Teva and Kashiv BioSciences/Alvotech disclosing Phase III comparison trials for their biosimilar products. Ahead of them in the pack, Celltrion has just taken a giant stride towards the first pan-European marketing approval.
Celltrion has emerged as the first company to win an EU recommendation for a marketing approval for a biosimilar to Genentech/Novartis’s Xolair (omalizumab), setting up a potential near-term launch with key Xolair compound and formulation patents having already expired or imminently about to run their course.
The Korean firm’s Omlyclo (omalizumab) 75mg and 150mg solution for injection in pre-filled syringe biosimilar has received a positive opinion...
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.
