Following its recent landmark approval for the first US generic version of AstraZeneca’s Symbicort blockbuster, Viatris has commented on the potential to move on a pre-patent expiry launch, amid a recent favorable court decision.
Viatris has confirmed that the recent US approval for its Breyna generic version of AstraZeneca’s Symbicort (budesonide/formoterol fumarate dihydrate) pressurized metered dose inhaler “presents an opportunity” for market entry in 2022, albeit “as upcoming court proceedings develop.”
The US Court of Appeals for the Federal Circuit had earlier vacated and remanded Viatris’ earlier stipulated judgment of infringement...
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.
