A biosimilar is a subsequent version of an innovator biologic product. Biosimilars are characterized by having the same amino acid sequence as the originator therapeutic and also nearly identical pharmacokinetics and biological activity. The US FDA states that a biosimilar should have no clinically meaningful differences from an existing FDA-approved reference product.
The demand for cheaper biotherapeutics has driven more research labs to develop biosimilars. While biosimilars have the potential to provide treatment at lower cost, development can be costly and take 5 to 9 years. When developing biosimilar programs, every biologic requires a specific sample preparation strategy and the demonstration of similar immunogenicity is a critical requirement for the demonstration of similarity between a biosimilar candidate and reference product.
This feature was produced in association with Covance