The European Commission has approved Stada and Xbrane’s Ximluci ranibizumab biosimilar, the third Lucentis rival to be approved in the region so far. The companies are aiming to launch in early 2023 in selected European markets.
The European Commission has granted a marketing authorization for Stada and Xbrane Biopharma’s Ximluci (ranibizumab) 10mg/ml solution for injection biosimilar rival to Lucentis. The authorization covers all 27 EU member states as well as Iceland, Norway, and Lichtenstein.
The authorization comes just over a year after the companies first filed in the EU for the Lucentis rival. (Also...
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.
