On April 23rd, President Biden signed into law S. 164, the “Advancing Education on Biosimilars Act of 2021,” which authorizes the Food and Drug Administration (FDA) to educate consumers and health care providers on biologic products, including biosimilars.
In March, the US Senate unanimously passed the bill, which directs the FDA to improve education on biosimilars with the goal of increasing uptake. Under the law, the FDA will create a biosimilars education website targeted at health care providers. Educational materials offered on the website may include:
- Explanations of key statutory and regulatory terms, including “biosimilar” and “interchangeable”, and clarification regarding the use of interchangeable biosimilars
- Information related to development programs for biological products, including biosimilars and interchangeable biosimilars, and relevant clinical considerations for prescribers
- An explanation of the process for reporting adverse events for biological products, including biosimilars and interchangeable biosimilars
- An explanation of the relationship between biosimilars and interchangeable biosimilars licensed under section 351(k) and reference products (as defined in section 351(i)), including the standards for review and licensing of each such type of biological product
Comparative data for originator biologics and biosimilars will also be made available; and, on an ongoing basis, the FDA will maintain continuing education programs to inform health care providers, including nurses, about biosimilars.
Read more about the Advancing Education on Biosimilars Act (S. 164) here.