Tanvex Biopharma submitted an application for biosimilar filgrastim as far back as 2018. Now, after multiple setbacks, the firm has celebrated becoming a commercial-stage company in the US.
Taiwan’s Tanvex Biopharma has welcomed “moving beyond being a clinical/developmental stage company to a commercial company in the US,” after receiving US Food and Drug Administration approval for its Nypozi (filgrastim-txid) biosimilar to Amgen’s Neupogen.
Nypozi, formerly known as TX01, is the first biosimilar filgrastim product approved by the FDA since Amneal’s Releuko (filgrastim-ayow) in...
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.
