# What Are Biosimilars?
Keywords: biosimilars, biologics, reference medicine, comparability studies, extrapolation, pharmacodynamics, pharmacokinetics

> This page provides an overview of biosimilars, explaining their characteristics, development process, regulatory requirements, and their role in treating chronic and life-threatening diseases.

## Details
- [What Are Biosimilars?](#): Biosimilars are biologic medicines engineered to be highly similar to an already authorized reference medicine.
- [Developing Biosimilars](#): Advanced technologies enable the development of high-quality biosimilars by matching the therapeutic attributes of the reference biologic.
- [Demonstrating Biosimilarity](#): Biosimilarity is proven through rigorous comparability studies to ensure no clinically significant differences with the reference medicine.
- [Extrapolation as a Basis for Approval](#): Extrapolation allows biosimilars to gain approval for clinical indications without new efficacy and safety data.
- [Summary](#): Biosimilars are complex proteins produced by living cells, designed to match the active substance of reference products, and authorized for similar therapeutic uses.