Abstract
The Food and Drug Administration (FDA) defines a "biosimilar" agent as a biologic that is highly similar to the reference or originator biologic product notwithstanding minor differences in clinically inactive components with no clinically meaningful differences in terms of the safety, purity, and potency. The advantage of biosimilars is that they are usually about 15%-30% less expensive than the reference product, which results in system-wide cost savings and increased patient access. Because biologic drugs are produced by living organisms, they are by nature heterogeneous and identical copies cannot be made, unlike generic versions of small-molecule drugs. Proposed biosimilars must undergo a rigorous evaluation process to demonstrate a high degree of structural and functional similarity with the reference biologic. Once that is confirmed, a stepwise process of comparison with the reference agent with regard to animal trials, pharmacokinetics/pharmacodynamics, immunogenicity, and human efficacy/safety is conducted. The experience with biosimilars in other highly regulated markets where patent protection for originator biologics is not as robust as in the United States has been favorable in terms of safety, efficacy, and cost savings. An FDA approval pathway was created in 2009 to expedite the approval of biosimilars; as of early 2018 nine agents had been approved through that pathway, none in nephrology. The first United States biosimilar epoetin was approved on May 15, 2018, but does not have an interchangeability designation, meaning that prescribers must specifically write for the biosimilar product for patients to receive it. Given the unfamiliarity of biosimilars within the nephrology community it is recommended that educational programs be developed to address this unmet need and for research to be conducted addressing the perceptual, clinical, and economic effect of biosimilars on our patients.
Highlights
A “biological product” is defined by the Food and Drug Administration (FDA) as a “virus, therapeutic serum, toxin, antitoxin, blood, blood component or derivative, allergenic product, protein, or analogous product . . . applicable to the prevention, treatment of cure of a disease or condition of human beings.” (1) Indications for currently available biologic drugs include cell therapy for cancer; clotting factors for hemophilia; cytokine or growth factors for cancer and hepatitis C; enzymes for hereditary deficiencies; mAb for arthritis, lupus, psoriasis, inflammatory bowel disease, multiple sclerosis, and cancer; polyclonal antibodies for immunodeficiency; toxins for cosmetic use; hormones; and vaccines for influenza and other viruses (2)
In 2009, the United States enacted the Biologics Price Competition and Innovation Act (BPCIA), which gives the FDA authority to approve a biosimilar drug for which the reference product is a previously licensed biologic approved through the 351 pathway
The first biosimilar agent was approved in the United
Summary
A “biological product” is defined by the Food and Drug Administration (FDA) as a “virus, therapeutic serum, toxin, antitoxin, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product . . . applicable to the prevention, treatment of cure of a disease or condition of human beings.” (1) Indications for currently available biologic drugs include cell therapy for cancer; clotting factors for hemophilia; cytokine or growth factors for cancer and hepatitis C; enzymes for hereditary deficiencies; mAb for arthritis, lupus, psoriasis, inflammatory bowel disease, multiple sclerosis, and cancer; polyclonal antibodies for immunodeficiency; toxins for cosmetic use; hormones; and vaccines for influenza and other viruses (2). The term “biosimilar” is correctly attributed to agents approved in highly regulated markets such as the European Union (EU), the United States, Canada, Japan, Australia, and New Zealand These products must meet strict criteria of quality and comparability to their respective reference biologics; after approval in highly regulated markets, the record of safety and cost savings is encouraging (5). In 2009, the United States enacted the BPCIA, which gives the FDA authority to approve a biosimilar drug for which the reference product is a previously licensed biologic approved through the 351 pathway. The problem was quickly identified and solved, but the EU withheld approval for SC Binocrit administration until 2016 These episodes reinforce the fragility of the manufacturing, packaging, and distribution process for biologic agents with regard to immunogenicity, even within highly regulated markets such as the EU.
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