Wednesday, May 15, 2019
FDA puts out Biosimilars Recommendations
Statement from Acting FDA Commissioner Ned Sharpless, M.D., on policy advancements to help bring interchangeable biosimilars to market
How does this affect the ADC market? As we mentioned last week, (Are ADCs just a fancy way to hold onto a patent?) biosimilars are coming for US Biologics, and ADCs could be an interesting path to keep a patent lasting a little longer, or to identify a new standard of care without all of the risk of a new molecule.
What do you think? Why aren't biosimilars flodding the market as expected?