FDA releases final guidance on interchangeable biological products

The Food and Drug Administration Friday issued final guidance clarifying how sponsors may show that a proposed biosimilar product is interchangeable with a brand name biological product. The guidance focuses on therapeutic protein products, one category of biological product. The Biologics Price Competition and Innovation Act of 2009 created an abbreviated licensure pathway for biosimilar products in an effort to increase competition for biological products and lower costs. Depending on state law, a biosimilar product that is interchangeable may be substituted for a brand name biological product at the pharmacy without the involvement of the prescriber, similar to how generic drugs are substituted for brand name drugs. Beginning next March under the BPCI Act, insulin products will be deemed biological products, meaning the guidance may also help biosimilar and interchangeable insulin products come to market.