Article
Gregory S. Calip, PharmD, MPH, PhD, Ivy P. Altomare, MD, Jenny S. Guadamuz, MSPH, PhD
A narrative review of biosimilars: a continued journey from the scientific evidence to practice implementation
Summary
- Biologic agents have significantly improved the management of serious health conditions over the last two decades, offering better treatment outcomes and quality of life compared to traditional chemotherapy.
- The cost of biologic drugs is high, leading to increased healthcare expenses. This mirrors the previous situation with branded chemical drugs, which was alleviated by introducing generics.
- As many biologics are reaching the end of their patent exclusivity, there is potential for biosimilars to enter the market and reduce costs through increased competition.
- However, market penetration of biosimilars is not guaranteed. Stakeholders need to have trust in biosimilars and their FDA-approved studies to incorporate them into practice.
- Disseminating scientific and emerging evidence on biosimilars is crucial to help stakeholders make informed decisions and benefit from expanded treatment options.
- The paper discusses the development and approval process of biosimilars, as well as challenges in their market implementation.
The simplest forms of biologic drugs entered the U.S. market in the 1970s and primarily consisted of blood products and vaccines. The rise of cloning and gene expression technology enabled biosynthesis of genetically modified organisms, which allowed the production of increasingly complex biologic molecules, including Genentech’s recombinant human insulin in 1982, the first FDA-approved monoclonal antibody and the entry of recombinant monoclonal antibodies in cancer treatment in 1997. Biologics, also known as therapeutic proteins, are medications produced in a laboratory to mimic natural proteins. This biologics mimic or antagonize a natural proteins function. Since then, biologics have revolutionized the treatment of serious medical conditions in the U.S. However, the high cost associated with biologic therapies along with increasing biologic utilization over the years have led to sharp increases in the overall healthcare cost curve. Table 1 provides a list of contributing factors as it relates to the increase of biologics utilization.
Biosimilars, interchangeability, extrapolation, immunogenicity
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