Both the EU and US have passed regulations allowing biosimilars. You know what they are. They are the copies of licensed drugs that have been developed by others. Somewhat akin to the generics of the drug world. The path to licensure of these biosimilars is more complicated than classic drugs. None have been licensed in the USA yet but they are off to a strong start in Europe and have been for several years where over 22 are on the market. Link to an article written recently on the topic on Master Controls GXP Lifeline e-journal.