Formycon has pushed its second ophthalmology biosimilar candidate into Phase III trials, the German firm’s Eylea (aflibercept) biosimilar, FYB203, which has been licensed to Bioeq. Multiple firms are now circling Eylea, ahead of a projected US market formation in 2023.
The race to break into the $7.5bn global Eylea (aflibercept) market continues to gather pace, with Formycon AG and partner Bioeq IP AG announcing that patients are now enrolling in their Phase III clinical trial investigating the comparable efficacy, safety and immunogenicity of the firms’ FYB203 biosimilar aflibercept candidate.
An update to the clinicaltrials.gov website shows the MAGELLAN-AMD trial, sponsored by Bioeq, involves 400 patients with wet age-related macular...
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.
