Alvotech has received a further complete response letter from the US FDA relating to its AVT02 proposed adalimumab biosimilar rival to Humira. The latest BsUFA goal date disclosed for the product is now just a few days ahead of a potential US launch.
Alvotech has received another setback on its attempts to gain US approval for its AVT02 biosimilar rival to Humira (adalimumab), after the US Food and Drug Administration issued a complete response letter over deficiencies at the firm’s Reykjavik manufacturing facility.
This followed an earlier CRL issued by the FDA over the high-concentration 100mg/ml version of adalimumab. (Also see "Alvotech...
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.
