Pfizer’s approval for trastuzumab in the US marks the fourth FDA nod for a biosimilar rival to Genentech’s Herceptin original. However, while two of those biosimilar sponsors continue to be engaged in patent litigation with the originator, Pfizer and Mylan have both struck settlement deals.
Pfizer’s Trazimera (trastuzumab-qyyp) biosimilar version of Genentech’s Herceptin has been approved by the US Food and Drug Administration (FDA).
The biosimilar – which is approved for treating human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing...
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.
