Biosimilars major Celltrion has announced further progress on its biosimilar Xolair candidate, as it faces off against the likes of Glenmark to introduce global competition to Genentech/Novartis’ blockbuster cardiovascular biologic.
Celltrion is making further strides on one of the significant ‘next wave’ biosimilar opportunities, kicking off a global Phase III trial for biosimilar Xolair (omalizumab) following approval for the firm’s investigational new drug application from Korea’s Ministry of Food and Drug Safety.
Phase III trials for the Korean firm’s CT-P39 biosimilar omalizumab candidate are scheduled to be conducted “through about 65 clinical...
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.
