Shortly after filing for a high-concentration biosimilar adalimumab product with partner Samsung Bioepis, Organon has provided in-depth commentary for its expectations around the impending formation of the market, forecasting a “free for all” six months post-formation.
Pharmacy benefit managers are keen for optionality for the impending launch of biosimilar Humira (adalimumab) products next year, in order to see “where the price could potentially spiral to” ahead of a potential “free for all” six months after market formation, according to adalimumab sponsor Organon.
Addressing delegates to the virtual J.P. Morgan Healthcare Conference, Organon CEO Kevin Ali forecasted that Humira promised to be a...
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.
