Background: Biosimilars provide opportunities for improving healthcare access and outcomes and reducing overall healthcare costs for patients with cancer.
Objectives: The purpose of this article is to explore the history of biosimilars, regulatory pathways, and barriers to biosimilar approval. This article also aims to describe the patient and clinician barriers to biosimilars use and the progress that has been achieved since the first biosimilar approval in Europe in 2006 and in the United States in 2015.
Methods: A literature search was conducted to retrieve articles that are highly relevant to the history of biosimilars development and regulatory pathways in the United States, Europe, Asia, and Canada. Patient and clinician perspectives on safety issues and concerns regarding immunogenicity and bioequivalence that limit use of biosimilars are also included.
Findings: Patient and provider concerns regarding immunologic patient safety issues, such as immunogenicity, lack of comparability, and low biosimilarity, still exist. The clinical safety, efficacy, and tolerability of biosimilars are among the top concerns in patients, prescribers, and clinicians.