Biosimilars: Manufacturing and Inherent Variation

The structure of biological products is typically more complex than small molecule drugs. As a result, biologics are often more complicated to manufacture, process, and purify. They are typically manufactured from living organisms (e.g., microorganisms, animal cells) and therefore, inherently contain many slight variations within lots that are manufactured at different times. This video shows the manufacturing process and how inherent variation occurs naturally in reference products, as well as biosimilar and interchangeable products. For more information, visit www.FDA.gov/biosimilars.