As the likely dynamics for US biosimilar competition to Humira come into sharper focus, Coherus has promised that its mid-2023 market entry with its just-approved Yusimry version will be accompanied by a “compelling value proposition,” months after rival Amgen’s biosimilar is expected to launch and around the same time as multiple other rivals are expected to hit the market.
Fresh from obtaining US Food and Drug Administration approval for its Yusimry (adalimumab-aqvh) biosimilar rival to Humira, Coherus BioSciences has promised to come to market with a “compelling value proposition” when it launches from 1 July 2023 under the terms of a settlement with originator AbbVie.
Coherus’ promise for Yusimry – the firm’s second approved US biosimilar, after the successful Udenyca (pegfilgrastim-cbqv) rival to Neulasta –...
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.
