What are the desired risk evaluation and mitigation strategies (REMS) for SEBs?
A number of risk management strategies were raised by most or all of the tables. • Registries of patient AEs/ARs, possibly including patient-reporting. • Periodic Safety Update Reports (PSURs), same frequency as reference product. • Tracking of specific products in case of adverse reaction • Education of patients and health care professionals about meaning of ‘similarity’. A number of suggested REMS components relate to the labelling and naming of SEB products. Participants want to avoid rapid switching or substitution between SEBs and innovators because this may create immunogenicity issues or inhibitors across a class of products. Participants propose to avoid this situation by providing clear warnings on labels, requiring SEBs to have a unique brand names and ensuring that patient prescriptions specify a brand name. One table suggested that the NOC should specify that Health Canada has not made a determination of interchangeability. There is no consensus as to whether SEB REMS shoul
