August 28, 2015.
The long-awaited draft guidance on biosimilar naming has been posted by FDA, reports BioPharm International's Randi Hernandez.
Within the document, the agency suggests naming follow-on biologics by a common nonproprietary name, followed by a suffix that will identify the manufacturer of the particular biosimilar. The naming scheme is consistent with the way the agency labeled Zarxio (filgrastim-sndz), the first biosimilar product to be approved by FDA. The naming convention will be used for all future biosimilar products and will also be applied retroactively, meaning the naming convention will apply to biologic products that are already on the market.
For more on this story, read the BioPharm International report here.
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.