Chemical drugs, like aspirin, are small molecules that are synthesized in a laboratory. Because they are derived from chemicals with fixed structures, they can be fully characterized by analytical techniques.
In contrast, biologic drugs, or biologics, are large, complex molecules designed to specifically interact with other protein molecules in the body. Due to their complexity, biologics can only be manufactured in living cells.
Because of this, biologics cannot be fully characterized, as can chemical drugs. Consequently, biologics require robust, extensive testing programs to ensure quality and consistency.
In the U.S., a biosimilar is a biological product that is highly similar to a previously approved or reference product notwithstanding minor differences in clinically inactive components. An approved biosimilar will have no clinically meaningful differences from the reference product in terms of safety, purity and potency.
To be highly similar, extensive analytical characterization to demonstrate similarity of structure in combination with safety and immunogenicity studies must be performed. Additional comparative clinical studies may be required if residual uncertainty regarding similarity in structure remains. Because a licensed biosimilar has demonstrated it is highly similar to the reference product, it can be approved to treat the same medical conditions as the reference product.
Biosimilars are already available worldwide through biosimilar approval pathways implemented in countries across the globe.
The European Union has been approving biosimilars since 2006. Other highly regulated markets such as Japan, Australia, and Canada have been approving biosimilars since 2010.
Millions of patients have already received treatment in highly regulated markets with the same level of safety and efficacy as the reference biologics.1
The first biosimilar was approved in the United States in 2015. As biosimilars become more prevalent and accessible, experts predict savings to the U.S. healthcare system could range from $44B to $250B through 2025.2