Biosimilars

Definition

Biosimilars are biologic medical products that are highly similar to an already approved reference product, with no clinically significant differences in terms of safety, purity, and potency. They undergo rigorous testing and regulatory review to ensure they match the original biologic.

5 Must Know Facts For Your Next Test

1. Biosimilars must demonstrate no clinical differences from the reference product.
2. They are generally less expensive than their reference biologics.
3. The approval process for biosimilars includes analytical studies, animal studies, and clinical studies.
4. Biosimilars can help increase access to essential treatments due to their lower cost.
5. The naming convention for biosimilars often includes a unique suffix to distinguish them from the reference product.

Review Questions

• What are the main criteria for a drug to be classified as a biosimilar?
• Why are biosimilars typically less expensive than their reference products?
• Describe at least two types of studies required for the approval of a biosimilar.

Related terms

Biologic: A drug derived from living organisms used in the treatment, diagnosis, or prevention of diseases.

Reference Product: An original FDA-approved biological product that serves as a comparison for evaluating biosimilars.

Interchangeable Biosimilar: A biosimilar that meets additional requirements to be substituted for the reference product without consulting the prescriber.