Sandoz has introduced the first generic version of Roche’s landmark treatment for idiopathic pulmonary fibrosis, Esbriet (pirfenidone), after downing the originator’s attempts to stymie its launch.
Fresh from a US court refusing to grant Roche’s Genentech a temporary injunction pending appeal of a comprehensive non-infringement ruling, Sandoz has launched at-risk the first US generic version of the originator’s Esbriet (pirfenidone) film-coated tablets to treat idiopathic pulmonary fibrosis.
Bolstering Sandoz’s respiratory portfolio, the launch also brings generic competition to one of only two drugs approved by the US...
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.
