Follow-on biologics have the potential to significantly reduce costs for patients requiring insulin therapy, according to a new study.
Follow-on biologics are copies of originator innovator biologics. The term is applied to both biologics submitted under the Food, Drug, and Cosmetic Act (FD&C Act) as new drug applications and also to those biologics submitted under the Public Health Service Act as a biologic license application.
“For example, the glargine insulin, Basaglar, was approved via the FD&C Act regulatory pathway. Thus, it is a follow-on biologic, but it is not a biosimilar,” stated authors led by Richard Dolinar, MD, of the Arizona Endocrinology Center in Phoenix. The number of follow-on biologics and biosimilars available in the US is likely to increase markedly in the coming years, including for many of the insulins used to treat diabetes, they noted.
The authors published their review in the February 2018 issue of Endocrine Practice.
Drugs are described as “follow-on biologics” or “biosimilars” depending on the way they are approved by the FDA—but not “bioidentical” or “generic”—because although they are similar, they are not identical to the reference product, which is the original biologic drug. Follow-on biologics and biosimilar drugs can be assumed to be similar enough to the reference biologic product to allow them to be used interchangeably.
Dolinar R, Lavernia F, Edelman S. A guide to follow-on biologics and biosimilars with a focus on insulin. Endocr Pract. 2018;24:195-204.