In a major move to get organized for the oncoming wave of biosimilar applications, the FDA has published a “Purple Book” listing licensed (e.g., approved) biologicals and licensed interchangeable biosimilars. Rather than summarize the contents table of the book, linked here is the publication from BIO’s new Intellectual Property Newsletter that links to the FDA press release from the FDA Blog.
FDA Publishes “Purple Book” for Biologicals/Biosimilars
FDA Publishes “Purple Book” for Biologicals/Biosimilars
Thursday, September 11, 2014