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Follow-On Biologic

What is a follow-on biologic?

A follow-on biologic is a copy of an original innovator biologic. However, because of the nature of biologics, it is not possible to copy their structure exactly, which can lead to possible differences in safety and efficacy.

A follow-on biologic is not the same as a generic drug. A generic drug is a product shown to be the same as an innovator drug and therapeutically interchangeable. However, follow-on biologics, which include biosimilars, are similar to, but not the same as, the innovator drug. As such, the drug approval pathway for generic drugs is inappropriate for complex biologics.

Follow-on biologics are regulated under the Federal Food, Drug, and Cosmetic Act and the Public Health Service (PHS) Act. They are approved through an abbreviated pathway, but they must still submit analytical studies (providing data on the follow-on biologics structural and functional similarity to the innovator biologic), animal studies, and clinical studies.

How do follow-on biologics improve healthcare?

Follow-on biologics have a similar purpose as the biologics they replicate: to prevent, treat, or cure a disease. They can include blood products, vaccines, human cells and tissues, allergenic extracts, gene therapies, and other biologically derived compounds.

Like generic drugs, follow-on biologics are usually cheaper than innovator biologics, meaning patients can access similar levels of care and treatment for a more reasonable price.