In one of the most keenly-watched markets, Viatris has emerged as the winner of approval for the first US generic version of AbbVie’s Restasis 0.05% ophthalmic emulsion, years after its IP was taken down. Numerous firms and analysts had acknowledged the complexity of the reference brand.
Approaching five years since its intellectual property was invalidated, AbbVie’s Restasis (cyclosporine) 0.05% ophthalmic emulsion finally has approved generic competition, drawing a line under one of the most controversial legal affairs in recent US pharma history.
Viatris’Mylan has won US Food and Drug Administration approval for its generic version of the former Allergan power...
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.
