Biosimilars

What are biosimilars?

Understanding biologic medicines, or biologics, is the first step in understanding biosimilars. These are generally large, complex molecules that are produced through biotechnology in a living system, such as a microorganism, plant or animal cell. They have revolutionized the way we treat various diseases offer treatment options for patients with chronic and often disabling conditions such as diabetes, autoimmune disease and cancer.

Biologic medicines are often more difficult to characterize than small molecule drugs due to inherent variations. Because of this natural variation, an exact copy, or generic, cannot be created. What can be created is a highly similar version, which has no clinically meaningful differences from an already approved biologic, or ‘reference product’.

When a regulatory agency, such as the FDA or EMA, deems a biosimilar candidate to be highly similar to the reference product in terms of safety and effectiveness, with no clinically meaningful differences, it is approved as a biosimilar. Biosimilars are as safe and effective as their reference biologics and are subject to the same quality standards.

Biosimilars offer additional treatment options, potentially lowering health care costs as they are typically more affordable. As reference biologics lose patent protection, there is incentive to support biosimilar market adoption by governments and payers because these lower cost alternatives can lead to cost containment and healthcare sustainability.

What are Biologics & Biosimilars?