Biosimilars: From Production to Patient

Abstract

Biologic drugs are large, complex molecules produced through biotechnology. A biosimilar is a biologic product that is highly similar to an already approved biologic (reference product), with no clinically meaningful differences in purity, safety, or efficacy; as such, a biosimilar does not need to undergo the same level of study in a clinical trial program as the original reference product. Due to the potential impact of biosimilars on patient access and health care systems, the US Food and Drug Administration introduced an abbreviated pathway for approving biosimilars (351[k]) in 2009. There is strong evidence that switching from a reference product to a biosimilar does not reduce treatment effectiveness or increase the risk of adverse events. Biosimilars may reduce costs and increase patient access to biologic therapies. Biosimilar use in the United States has increased, as have the associated biosimilar cost savings, which are expected to reach $104 billion between 2020 and 2024. Yet, a need remains for increased knowledge among health care professionals and patients. Prescriber confidence is key to patient acceptance of biosimilars and minimizing the incidence of the nocebo effect. Infusion nurses are well positioned to help educate patients and to improve clinical outcomes across a range of diseases.

Figure 1

Biosimilars approved for use in the United States, as of March 2023.,– Abbreviation: FDA, Food and Drug Administration.

Figure 2

Studies required in the development of biosimilars, in comparison with new biologics.,, ^aAs needed. Abbreviations: PD, pharmacodynamics; PK, pharmacokinetics.

Figure 3

Estimated biosimilar savings in the United States. Abbreviation: Bn, billion.