In recent years, biologics have increasingly been used for the treatment and supportive care of patients with various serious illnesses, including cancer. These agents, which include therapeutic proteins and monoclonal antibodies, are large complex molecules typically manufactured in genetically engineered organisms. Although biologics have been shown to be very effective in the treatment of many types of malignancies, they are also among the most expensive oncology drugs on the market in the United States. The high price tag associated with biologics can be attributed to several factors, including a costly manufacturing process and the large investment in research and development necessary to take them through clinical trials and the FDA approval process.
The cost of biologics, coupled with recent patent expirations of several of these agents, has led to the development and approval of several biosimilars for the treatment of cancer and other conditions. A biosimilar is a biologic that is highly similar to, and has no clinically meaningful differences from, another biologic that is already approved by the FDA.
Although biosimilars have the potential to reduce healthcare costs, increase competition, and improve patient access to highly effective biologic agents, there are hurdles that must be addressed before the full potential of these agents can be realized. Perhaps one of the largest hurdles to the integration of biosimilars is the acceptance of these agents by physicians and patient consumers. To overcome this hurdle, it is essential that we close major knowledge gaps regarding the safety and efficacy of biosimilars and their successful adoption in clinical practice. These gaps include defining biologics versus biosimilars in the context of biosimilarity, understanding the approval process and the use of the “totality of evidence” approach by the FDA for biosimilar evaluation, understanding the evidence requirements
for demonstration of safety and immunogenicity of a biosimilar versus its reference product, and defining interchangeability in the context of pharmacy-level substitution.
Oncology pharmacists will play an increasingly important role in educating prescribers and patients regarding the particulars of switching from reference biologics to biosimilars. They can also answer questions and address common misconceptions regarding safety and efficacy issues that may deter the use of these agents. The purpose of this special issue of The Oncology Pharmacist (TOP) is to provide pharmacists with the information they need to take the lead in these important conversations.
We hope you will enjoy this special issue of TOP, and we invite you to visit www.TheOncologyPharmacist.com to share your feedback about this issue with us or send comments to