BIO Principles on Follow-On Biologics

In order to ensure that new pioneer biotechnology products continue to reach patients and physicians, any statutory pathway for the approval of follow-on biologics must protect patient safety and preserve incentives to innovate.

"Biologics" are complex medicines that are manufactured using living organisms. These drugs are different and far more complex than most small molecule chemical drugs, and include many of the latest breakthrough medical therapies for serious and life-threatening illnesses, such as cancer, multiple sclerosis, diabetes, and HIV/AIDS, as well as many serious rare diseases. Due to their size and complexity, biologics generally cannot be scientifically characterized to the same degree as small molecule chemical drugs.

Follow-on biologics are not generic drugs. A generic drug is a product that is shown to be the same as an innovative drug, and is generally designated as therapeutically interchangeable with the innovator drug. Unlike generic drugs, a follow-on biologic (or "biosimilar") is a product that is similar to, but not the same as, the innovator drug. Because of the complex science involved, the Food and Drug Administration (FDA) and foreign regulators have indicated that the generic drug approval pathway is not appropriate for complex biologics.

As Congress explores the creation of any regulatory pathway for follow-on biologics, it is essential that Congress recognize and adopt the following key principles: