During this half-day program, thought leaders and industry experts will engage in an open and balanced dialogue—with audience participation—on biosimilars naming and labeling issues. Exploring issues that have not yet been addressed publicly by FDA, this discussion will, for example, address whether and how to identify a reference biologic and its biosimilar through naming and in labeling. We will ask “what’s in a name” and how many goals a nonproprietary name should satisfy. We will discuss what studies should be included in a biosimilar biological product’s package insert and whether FDA can or should address substitution practices and interchangeability questions through labeling. The November 16 Dialogue will be equally important to companies developing innovative biologics and companies developing biosimilars, and should be valuable for professionals with regulatory, scientific, or legal perspectives. FDLI invites all attendees to join the conversation.