"Biologics" are complex medicines that are manufactured using living organisms.
Further, any such pathway must require that FDA follow a transparent and public process in determining data requirements for the approval of specific follow-on biologics.
Continue to Prioritize FDA Review and Approval of New Therapies and Cures. Any applications for approval of follow-on biologics will raise novel and complex questions of science and law, requiring substantial time and additional resources to ensure a thorough regulatory review for safety, purity, and potency. In order to avoid slowing down FDA's review and approval of new therapies and cures, many for currently untreatable and serious diseases, Congress must ensure that workload associated with these new applications does not harm FDA's ability to efficiently review new drugs and biologics, and that new treatments continue to have the highest review priority.