Biosimilars are FDA-approved medications that are biological in type and contain a very similar substance that has been previously approved by the FDA. Similar to other generic medications, biosimilars offer an opportunity for lower healthcare costs due to intrinsic price competition with the originator (reference) product. Providers and healthcare organizations require an understanding for biosimilars and their appropriate use in order to know how to implement these medications into their practice and how to explain these medications to patients. In this vein, an understanding of how biosimilars are regulated by the FDA, approved, and even paid for is important for all stakeholders involved in the treatment of cancer and associated diseases. The federal government and the insurance companies have heavily pressed for the use of biosimilars in the healthcare arena.

Dating back to 1984 when the Drug Price Competition and Patient Term Restoration Act (Hatch–Waxman Amendments) became a law, the use of FDA-approved generic medications was permitted without having to repeat the original research previously established by the brand drug’s safety and efficacy results. At the time of approval, many medications were chemically synthesized; therefore, generic medications based upon the originator medication were structurally identical. However, ongoing innovation in the pharmaceutical industry would challenge this brand-generic structural component similarity, with Eli Lilly developing a method to use bacteria to synthesize insulin utilizing recombinant DNA. As a result of this research effort, the biologics drug category was established, differentiating from other medications by involving the use of living organisms [1].

Decades later, the biosimilar drug class continues to successfully reproduce their originator medication’s components and efficacy, serving as a biologic generic medication alternative. These biosimilars contain similar versions of the active living substance and components of their originator biologic medication (originator product), while offering an FDA-approved quality, safety, immunogenicity, and treatment efficacy in comparative studies [1].