What are biosimilars?

Biosimilars are defined as biological products that are clinically similar to the reference product, which is typically an already approved biologic. Unlike generic drugs that can be exact copies of chemical compounds, biosimilars are not identical due to the complex nature of biological products, which are often made from living organisms.

The development process for biosimilars involves comprehensive studies to ensure that the biosimilar behaves in a similar manner to the reference product in terms of safety, efficacy, and immunogenicity, but they may differ in terms of clinical outcomes because of the inherent variability in biological systems. This is crucial for healthcare providers and patients when considering treatment options, especially since biosimilars can offer more affordable access to important therapies.

Biosimilars are thus positioned to provide similar therapeutic benefits as their reference products, making them a valuable option in the field of pharmacotherapy.