Not that it needed spelling out, but Organon’s CEO Kevin Ali wished to make sure there were no uncertainties.
“That’s going to be the largest loss of exclusivity event in the history of the pharma market in the US,”...
Humira One Year Out: The Largest LOE Event In US Pharma History
Amgen’s Amjevita Biosimilar Set To Launch On 31 January 2023 With Many More To Follow
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Ahead of the first biosimilar Humira product set to launch in 365 days, Generics Bulletin provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.
Stay ahead of every shift in generics and biosimilars.
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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.
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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.
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Teva and Biocon Biologics have become the latest firms to sign up to the Biosimilars Forum industry association in the US.
