Biocon and Viatris have landed their second biosimilar insulin approval in Europe, for a rival to Novo Nordisk’s NovoRapid (insulin aspart). Analyst reaction was lukewarm considering the “disappointing” launch of insulin glargine in Europe more than two years ago.
The European Commission has rubberstamped a recommendation for approval for the Kixelle (insulin aspart) biosimilar to Novo Nordisk’s NovoRapid, handing a significant marketing authorization to the newly-formed Viatris and its development partner Biocon.
“While management has not indicated specific launch timing of the approved Kixelle, we believe it will be commercialized during the...
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.
