We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » FDA Draft Guidance Outlines Steps for Earning Biologic Exclusivity
FDA Draft Guidance Outlines Steps for Earning Biologic Exclusivity
The FDA will grant marketing exclusivity only to biologics that are fundamentally different from existing products, according to new guidance that explains what manufacturers must do to lock in protection from biosmiliar competition.