Biosimilars: Exclusivity Guidance Possible; Head-To-Head Comparison Studies Sinking In
FDA’s Denise Esposito says that in many cases the agency will require biosimilar sponsors to conduct head-to-head comparison studies with the reference product.
FDA’s Denise Esposito says that in many cases the agency will require biosimilar sponsors to conduct head-to-head comparison studies with the reference product.