Biosimilars Development and Regulatory Pathways

Biosimilars Development & Regulatory Pathways

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.