Samsung Bioepis has celebrated the FDA’s first ever approval of an ophthalmic biosimilar with its endorsement of the firm’s Byooviz ranibizumab rival to Lucentis. The firm has also signaled a surprising expected launch date in the US, as well as offering expectations for launch in Europe where the biosimilar was also recently approved.
Samsung Bioepis has seen its Byooviz (ranibizumab-nuna) biosimilar to Genentech’s Lucentis approved by the US Food and Drug Administration, marking the agency’s first ever approval of a biosimilar with ophthalmic indications.
At the same time, the joint venture between Samsung Biologics and Biogen has revealed launch date expectations for the SB11...
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.
