Biologics are medicines made from living cells through highly complex manufacturing processes. They must be handled and administered under carefully monitored conditions. Biologics are used to prevent, treat, diagnose, or cure a variety of serious and chronic illnesses including cancer, chronic kidney disease, autoimmune disorders, and infectious diseases. A biosimilar is exactly what its name implies — it is a biologic that is “similar” to another biologic drug already approved by the FDA. Under U.S. law, a biosimilar is approved based on a showing that it is “highly similar” to an FDA-approved biological product, known as a reference product. It may not have any clinically meaningful differences in terms of safety and effectiveness from the reference product.
In 2010, Congress approved the Biologics Price Competition and Innovation Act (BPCIA), creating an abbreviated approval pathway for biosimilars, while maintaining incentives for continued medical advances. The legislative intent was to balance the desire for increased competition among biologics from biosimilar products with the need for incentives to support future medical innovation. Congress achieved this balance by providing biopharmaceutical innovators with 12 years of data protection for biologic medicines. To date, the FDA has issued several draft and final guidance documents to assist biosimilar sponsors in generating data to support biosimilar applications. FDA guidance and regulations provide insight into the agency’s current thinking regarding how it will evaluate biosimilar biological products. The FDA approved in March 2015, the first biosimilar product for marketing in the United States.