Sandoz is looking to move ahead with its planned filings for one of the most significant off-patent biologic opportunities in the coming years – Eylea (aflibercept).
Sandoz says it is optimistic of filing its proposed biosimilar to Regeneron/Bayer’s Eylea (aflibercept) in the US and the EU “in the coming months” after announcing confirmatory efficacy and safety data for its ophthalmology from the company’s ‘Mylight’ Phase III study.
Several rival biosimilar sponsors have already made progress with aflibercept biosimilar filings, including in the US Celltrion, Formycon/Coherus and Biocon/Momenta,...
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.
