The California-based biosimilars player has come good on its promise to introduce early in the new year its first biosimilar in the US and the second biosimilar of Amgen’s Neulasta blockbuster; at the same time, biotech veteran Darlene Horton has joined Coherus’ management team.
Coherus BioSciences has launched its Udenyca (pegfilgrastim-cbqv) 6mg/0.6ml pre-filled syringes biosimilar to Amgen’s Neulasta in the US, matching the 3 January launch date promised by management upon US Food and Drug Administration (FDA) approval last November.
Days earlier, “biotechnology leader” Darlene Horton joined the California-based player as chief medical and regulatory affairs officer, lauding the “significant...
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.
