A third US biosimilar to Regeneron’s Eylea has won approval. However, enthusiasm is muted at this stage as biosimilar sponsors, including latest recipient Formycon, continue to battle against court-issued blockades.
Formycon and its licensing partner Klinge Biopharma have become the third biosimilar sponsors to pick up a US Food and Drug Administration approval for a rival to Regeneron’s Eylea (aflibercept) 2mg in less than two months, with a nod for their Ahzantive (aflibercept-mrbb).
The approval is “another key milestone on our way to becoming the leading pure-play biosimilar developer,” Formycon believes, while helping...
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.
