What Are Biosimilars? Biosimilars are pharmacologic agents created to mimic the structure and function of a biologic already approved by the FDA. The biologic the biosimilar is made based on is called the reference drug.

Biosimilar production may use different materials but must be used to treat the same disease using the exact mechanism, efficacy, and safety as the reference drug. There must be no clinically meaningful difference between the two products. Thus, the relationship of a biosimilar to a biologic may be thought of similarly to the relationship between a generic and their corresponding brand name drugs.


What Are The Advantages of Biosimilars?

Advantages of biosimilars include:

  • Reduction in cost for patients and payors.
  • Increased competition and drive for the production of novel treatments for the disease.
  • Greater access to treatment.

Source: ResearchBiosimilars. U.S. Food And Drug Administration. Retrieved March 7, 2023, from