; (B) how the Secretary determines the safety, purity, and potency of biological products that are the subjects of applications under subsections (a) and (k) of section 351; (C) the application of the same quality and manufacturing standards for biological products under 351(a), biosimilar biological products under 351(k), and interchangeable biological products under 351(k)(4); (D) the development program and totality of the evidence required for biosimilar biological product development and how prescribers can evaluate such information; (E) the process for reporting adverse events for all biological products, including biosimilar and interchangeable biological products; (F) the relationship between— (i) variation among biological products licensed under section 351(k) and their reference products licensed under section 351(a); and (ii) lot-to-lot variability for a biological product licensed under section 351(a) or section 351(k) (including interchangeable biological products); (G) how the Food and Drug Administration assesses data regarding the risk of immunogenicity for originator biological products licensed under section 351(a) and biosimilar biological products licensed under section 351(k); (H) whether the role of analytical characterization is novel to biosimilar biological product development