6 March, 2015.
FDA today approved Novartis's Zarxio (filgrastim-sndz), the first biosimilar product approved in the US.
Sandoz's Zarxio is biosimilar to Amgen's Neupogen (filgrastim), which was originally licensed in 1991. FDA reports that Zarxio is approved for the same indications as Neupogen, and can be prescribed by a health care professional for:
For this approval, FDA has designated a placeholder nonproprietary name for this product as “filgrastim-sndz.” The Agency said that the "provision of a placeholder nonproprietary name for this product should not be viewed as reflective of the agency’s decision on a comprehensive naming policy for biosimilar and other biological products". FDA has not yet issued draft guidance on how current and future biological products marketed in the United States should be named, but "intends to do so in the near future".
The Impact of Artificial Intelligence on the Creation of Medicines
October 24th 2024Najat Khan, chief R&D officer, chief commercial officer, Recursion, and Fred Hassan, director, Warburg Pincus, discuss how artificial intelligence can help reduce healthcare costs at the 20th Annual Young & Partners Pharmaceutical Executive Summit held at the Yale Club of New York.
Plan Ahead: Mastering Your AI Budget for 2025 Success
October 9th 2024Generative AI is just one part of the artificial intelligence and machine learning that is being used by life science organizations, emerging as a major area of interest and an area in which costs and ROI are still largely unknown.