The development, approval, and manufacturing of biosimilars is a nuanced and complex process. In addition to ensuring quality, biosimilar manufacturers must ensure there are no clinically meaningful differences in terms of safety, purity and potency between the biosimilar product and its reference biologic. The links below provide an introduction to this process, in addition to resources that take a deeper dive into the nuances of biosimilar development and the regulatory approval pathways for biosimilars in the United States.
In addition to many of the complexities of manufacturing biologics, biosimilar development also has its own set of intricacies.
Extrapolation has the potential to reduce or eliminate the need to study a proposed biosimilar with clinical trials in every indication of the reference biologic. But it is not an automatic process.
Clinical testing is designed to help identify any clinically meaningful differences between a proposed biosimilar and the reference product.
Biosimilar regulatory approval pathways in the US require the manufacturer to demonstrate similarity to the reference biologic in terms of quality, safety and efficacy.