What is a Biosimilar Product?
- A biosimilar is a biologic medication that is highly similar to and has no clinically meaningful differences from an existing FDA-approved biologic, called a reference product.
- While biosimilars are similar to their reference biological product, they are not generic equivalents.
- Biosimilars go through a rigorous FDA review process including analytical, animal and clinical studies. The biosimilar approval process provides assurance that biosimilars provide the same treatment benefits and risks as their respective reference products
What do biosimilars offer?
- Expanded treatment access for patients with complex diseases
- FDA-approved safe and effective treatments
- Potential for substantial cost savings on expensive therapies
- Economic Opportunities for your health system
As more biosimilars become available in the U.S., health systems, payers and patients all stand to benefit from further incorporating these safe and effective therapies throughout our healthcare ecosystem.