Amgen has confirmed its long-awaited launch of Amjevita, the first US biosimilar rival to Humira, kicking off a year of competition that will also see a second wave of adalimumab products launch in six months’ time. The company has announced that it will offer the product at a 55% discount to the originator.
Amgen has confirmed its expected and long-awaited launch of its Amjevita (adalimumab-atto) 50mg/ml biosimilar rival to Humira in the US, for the first time offering details of a 55% discount to the brand price for the debut competitor to a blockbuster that has in recent years racked up record-breaking sales above $17bn in the US alone.
“Amjevita 40mg is available at a list price (wholesale acquisition cost) 55% below the current Humira list price,” Amgen announced,...
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.
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