Biden signs new generics, biosimilars legislation

April 26, 2021

President Biden has signed into law two pieces of legislation designed to improve biosimilar and generic drug uptake.

The two bipartisan bills — the Advancing Education on Biosimilars Act and the Ensuring Innovation Act — were passed by the Senate in March and the House in mid-April.

The Advancing Education on Biosimilars Act will require more robust federal efforts to educate about biosimilars, tasking the FDA with advancing education and awareness among health care providers, including by developing or improving continuing education programs. The bill also says the FDA should maintain a website to provide educational materials for health care providers, patients and caregivers, regarding the meaning of the terms, and the standards for review and licensing of biological products, including biosimilars.

The Ensuring Innovation Act will impose more restrictions on which biologics and generics drugs qualify for product exclusivity protections. The act will ensure the FDA has the ability to curb the practice of evergreening — extending their patents for five years when they make minor, insignificant changes to a drug — closing the loopholes on protections that don't represent true innovation.