European regulators have accepted for review a marketing authorization application for the first ‘China-developed’ biosimilar, a version of Roche’s blockbuster breast-cancer drug Herceptin (trastuzumab) developed by Chinese biotech firm Henlius.
Marking a major first step toward the opening of global markets for made-in-China biosimilars, Shanghai Henlius Biotech has announced that the European Medicines Agency has accepted for review an application for marketing its HLX02 trastuzumab biosimilar version of Roche’s breast-cancer drug Herceptin.
It is the first time the EMA has accepted a marketing authorization application for a “China-developed” biosimilar. The EMA’s decision...
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.
