FDA Streamlines Biosimilar Development to Lower Drug Costs

The U.S. Food and Drug Administration today announced another major step in its initiative to streamline the development of biosimilar medicines, which are like “generic” versions of biologic drugs.

In new draft guidance issued today, the agency recommended streamlining unnecessary clinical pharmacokinetic (PK) testing when scientifically justified. This change could save biosimilar developers up to 50% of their PK study costs, or approximately $20 million, and help lower drug costs.

"Streamlining biosimilar development reflects our ongoing commitment to lowering drug costs for everyday Americans," said FDA Commissioner Marty Makary, M.D., M.P.H. "Using common sense, we are embracing more precise analytical testing approaches than have been used in the past." Biologic medicines can be powerful treatments for many diseases, including autoimmune diseases and cancer, but are often expensive.

Despite accounting for just 5% of prescriptions, biologics account for 51% of drug spending, and commonly cost hundreds of thousands of dollars per year. Biosimilars, like generic drugs, can give patients more affordable treatment options and increase access to medications that are otherwise unaffordable.