Sandoz and Polpharma Biologics have obtained US Food and Drug Administration approval for their Tyruko natalizumab biosimilar rival to Biogen’s Tysabri. The approval follows a recent endorsement from the European Medicines Agency.
Sandoz and Polpharma Biologics are celebrating the second major regulatory nod for their biosimilar rival to Biogen’s Tysabri (natalizumab), after the pair’s partnered Tyruko (natalizumab-sztn) version received US Food and Drug Administration approval.
Developed by Polpharma Biologics, the biosimilar saw its global commercialization rights licensed to Sandoz under a 2019 deal.
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.
