§263–1 Education on Biological Products

Summary

The Secretary may run a public website with easy-to-understand materials for health care providers, patients, and caregivers about biological products, including biosimilar and interchangeable biosimilar products. The site can explain key terms like “biosimilar” and “interchangeable,” give basic info on how these products are developed and compared, show how to report side effects, and explain how biosimilars and interchangeable biosimilars relate to reference products licensed under section 262(k) and defined in section 262(i). Materials can be webinars, videos, fact sheets, infographics, toolkits, or other useful formats and can be tailored for different audiences. The Secretary will keep publishing the action package or the summary review for each biological product licensed under subsection (a) or (k) of section 262. The site cannot disclose trade secrets, confidential commercial or financial information, or other records protected under section 552(b) of title 5. The Secretary must also promote and improve continuing education for health care providers about prescribing and clinical issues for biological products, including biosimilars and interchangeable biosimilars.