ECRM_1170x120_1-10-22

Eva Temkin is a partner in King & Spalding’s FDA & Life Sciences practice.

Biosimilars are key to competition

Biosimilars are key to competition

It has been a big fall for interchangeable biologics. President Biden’s Executive Order 14036, “Promoting Competition in the American Economy” directed the Department of Health and Human Services (and the Food and Drug Administration), and HHS subsequently published its “Comprehensive Plan for Addressing High Drug Prices.” Interchangeable biosimilars are front and center in both of