What are Biosimilars

A biosimilar is a version of a biologic medication that is made by a different company than the one that invented it, with no clinically meaningful differences in terms of safety, potency and purity.

A biosimilar is not an exact copy of its reference product, but this is normal for biologic manufacturing. Much like the way the regulatory bodies such as the U.S. Food and Drug Administration (FDA) require clinical trial data and other evidence to approve a biologic, the totality of evidence for a biosimilar candidate must show a robust body of data to demonstrate biosimilarity.

Biosimilars vs. Generics

The biosimilar development process is inherently complex and requires a high degree of technical innovation and regulatory expertise.

Unlike small molecule drugs that are chemically synthesized and can be copied exactly in the form of a generic, biologics and biosimilars consist of large complex molecules (e.g., monoclonal antibodies) that are manufactured using living cells, extracted, and purified. Since biologics are cultured from living organisms, it is not possible to develop an identical copy of the reference product. This is also true batch to batch for the reference product and for biosimilars making new versions of the reference product.

Biosimilarity vs. interchangeability

A biosimilar is not Interchangeable unless the FDA says it is. An Interchangeable biosimilar first must meet the high FDA standards of a biosimilar—then, in order to achieve the Interchangeable designation, the FDA generally requires an additional study of multiple substitutions in patients – known as an Interchangeability study. This study shows how patients do when they are switched back and forth multiple times from a reference product to the Interchangeable biosimilar candidate.

A biosimilar with an Interchangeable designation may be auto-substituted for the reference product by a pharmacist. Individual state laws control how and whether providers must be notified.