FDA Public Meeting: Approval Pathway for Biosimilar and Interchangeable Biological Products

Sara Radcliffe, executive vice president of health for BIO, presented at a Food and Drug Administration public hearing on the approval pathway for biosimilar and interchangeable biological products. The key issues she discussed included: interchangeability; naming and labeling; confidentiality of information; reference product and non-U.S. data; patent certification; transition products; and guidence for the implementation of BPCIA.