FDA comes out with ‘Purple Book’ to catalog biologics and biosimilars
In a move that heralds greater momentum toward regulating biosimilars, the Food and Drug Administration has published its first-ever “Purple Book” – a list of all FDA-licensed biologics and the biosimilars that can be used in their stead. It’s meant to be equivalent to the FDA’s “Orange Book” – the go-to list for physicians, regulatory agents and […]