Celltrion has begun a Phase III study with a subcutaneous version of its infliximab biosimilar in the US, after the FDA allowed it to skip Phase I and II trials based on approval data in Europe, enabling a lower development time and cost.
Celltrion Inc. has begun to recruit patients for a US Phase III trial with a subcutaneous version of its infliximab biosimilar Remsima (CT-P13 SC) for inflammatory bowel disease, after it agreed with the FDA earlier this year to skip Phase I and II trials based on a vast amount of European approval data.
Celltrion told Scrip that it had taken a biosimilar (line extension) pathway in Europe, while in the US it has...
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.
