As Fresenius Kabi receives US FDA approval for its Idacio rival to Humira, positive developments are being seen in terms of adding adalimumab biosimilars to local formularies. Meanwhile, in Europe Stada and Alvotech have broadened access to their Hukyndra high-concentration version.
The latest approval for a Humira (adalimumab) biosimilar has been issued by the US Food and Drug Administration, this time for Fresenius Kabi’s Idacio (adalimumab-aacf) version of the top-selling biologic that is due to face US competition in 2023.
Fresenius said that Idacio – a citrate-free 40mg/0.8ml formulation of adalimumab that will be available in both a self-administered pre-filled...
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.
