Dr. Scott Kjelson, PharmD, host of the PolitiTalkRx Podcast welcomes Edward Li, PharmD, working within Health Economics and Outcomes Research to better understand the value of drugs and biologics. Today Scott & Edward dive into the topic of Biosimilars.
A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company.
Congress, through the Biologics Price Competition and Innovation Act (BPCI Act) of 2009, created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product. This pathway was established as a way to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition.
FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference product.