What is a Follow-On Biologic?
A follow-on biologic, also known as a biosimilar or a biogeneric, is a generic version of a biological drug. We refer to them as follow-on biologics since they “follow on” after a brand product biologic’s approval by the Food and Drug Administration. Biologics are produced from living cell cultures rather than synthesized chemically and include products such as vaccines, blood and blood components, gene therapy, tissues, and recombinant therapeutic proteins. Biologics are isolated from a variety of natural sources - human, animal, or microorganism - and may be produced by biotechnology methods and other cutting-edge technologies, often making them very expensive.
Follow-on biologics are like generic drugs, but with significant differences. Generic drugs that are currently available are synthetically exact copies of the brand name original, based on a precise chemical composition. Follow-on biologics, on the other hand, are similar to the brand name but are not exact copies. Technologies to ensure biologic “copies” are not currently available. Because exact copies cannot be produced, it is extremely important that product testing procedures show that a new follow-on biologic is clinically comparable to the brand name product.
Creating a Regulatory Pathway for Follow-On Biologics:
Currently, the Food and Drug Administration does not have authority to approve follow-on biologics for consumption by the public and to compete with their pioneer counterparts.
Generic drugs have been extremely successful in bringing down the high cost of prescription drugs. Generic drugs save patients and taxpayers billions of dollars each year. But currently there is no generic competition for one of the fastest growing and most expensive category of drugs known as biological drugs.
PAN supports the creation of an approval pathway for safe generic and interchangeable biological products while preserving incentives that spur the development of these life-saving medicines. It is our hope that an approval pathway for follow-on biologics will protect patient safety, lower prices, and expand access to these innovative drugs.
Recent Congressional Action
The health reform legislation crafted on Capitol Hill in 2009 includes language that would create a regulatory pathway for follow-on biologics. The House-passed bill, the Affordable Health Care for America Act, and Senate-passed bill, the Patient Protection and Affordable Care Act, would authorize the FDA to approve follow-on biologics for use by consumers. Both pieces of legislation establish a 12 year exclusivity period, meaning that biologic drug makers would have 12 years before a generic version could be sold to the public.