FDA Approves First Biosimilar Medicine in the U.S.

The U.S. Food and Drug Administration (FDA) recently announced its approval of Zarxio, the first biosimilar medicine in the United States. Biosimilars are therapies which have no clinically meaningful differences from innovator biologics—revolutionary medicines that treat chronic and life-threatening conditions. Biosimilars have the potential to significantly impact the healthcare system by increasing patient access to life-saving treatments while also reducing costs.

The Healthcare Supply Chain Association (HSCA) applauded the approval of Zarxio because it represents the first step in providing other biosimilars a pathway to market. Biosmilars will increase market competition for biologics, reduce costs and increase patient access to these vital medications. In fact, one study projects biosimilars could save the healthcare system as much as $250 billion over the next ten years.

HSCA President Curtis Rooney said the following on the approval of Zarxio:

Biologic medicines have revolutionized treatment for many patients living with chronic or life-threatening conditions, but their high price has also created a barrier to access in many cases. Biosimilars promise to increase access to biologic treatments while also lowering costs for the entire healthcare system.”

For HSCA president Curtis Rooney’s full statement, click here.

For more information on HSCA, click here.