Alvotech’s high confidence for FDA approval for its Stelara biosimilar has been justified, as the Icelandic firm announced only the second US approval for a rival to J&J’s Stelara powerhouse brand, ahead of market formation in 2025.
Alvotech has secured US Food and Drug Administration approval for its Selarsdi (ustekinumab-aekn) subcutaneous injectable biosimilar to Stelara, the Icelandic firm’s second major US biosimilar approval in the last two months and a significant boost for its commercialization partner Teva ahead of expected launch in February 2025.
The Icelandic firm announced its approval late on Tuesday for its biosimilar interleukin-12 and -23 antagonist for the treatment of...
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.
Amneal has marked its entry into China after receiving its first product approval in the market. Meanwhile, the firm has also outlined US approvals for two generics currently suffering from shortages.
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.
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.
