Stada and Alvotech’s Uzpruvo ustekinumab biosimilar is set to become the EU’s first approved rival to Stelara after the EMA’s CHMP issued a positive opinion for the product. Meanwhile, the committee also endorsed a Lucentis biosimilar from Qilu Pharma as well as azacitidine and paclitaxel generics from Fresenius Kabi and Accord.
Alvotech and Stada are in line to obtain the first European approval for a Stelara (ustekinumab) biosimilar after their partnered Uzpruvo version – previously known by the codename AVT04 – received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
While CHMP positive opinions do not constitute formal approval, the European Commission typically acts within 67 days to convert them...
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.
