FDA Action on Biosimilars Signals Progress for Patients and Employers

The FDA’s effort to streamline biosimilar development is a welcome step toward improving access to lower-cost medicines while maintaining the rigorous standards that ensure patient safety and efficacy. By reducing unnecessary regulatory complexity and modernizing the biosimilar review process, the agency is helping encourage competition that can drive down costs for patients, employers, and health plans.

“Biosimilars offer safe, effective, and more affordable alternatives to brand-name biologic medicines, yet regulatory complexity has too often slowed their path to market,” said Bret Jackson, president and CEO of the Economic Alliance for Michigan (EAM). “The FDA’s action to simplify and modernize the biosimilar development process will help lower development barriers and accelerate patient access to high-quality, lower-cost treatment options. Steps like this are essential to improving affordability for patients, employers, and the health care system as a whole.”

Biosimilars are like the “generic” versions of biologics. Currently, biologic medicines represent only about 5% of prescriptions in the U.S. but account for roughly 51 percent of U.S. drug spending. CLICK HERE to read the recent FDA press release highlighting the new draft guidance for biosimilars.