Biosimilars are biological medicines that are highly similar to the reference product with no meaningful clinical differences in terms of safety, purity and potency. All biologicals are produced by living cells resulting in an inherent heterogeneity in their higher order structures and post-translational modifications.
In 2010, the US Congress enacted legislation to streamline the approval process for biosimilars of products losing patent protection, with the goal of decreasing costs and improving patient access to therapeutically important but expensive biologicals. In 2015, the US Food and Drug Administration (FDA) approved the first biosimilar through this pathway.
Approval of additional biosimilars in the US, including those used by nephrologists, is anticipated. Given the relative lack of knowledge regarding biosimilars, their approval process and a lack of trust by the nephrology community regarding their safety and efficacy, the National Kidney Foundation conducted a symposium ‘Introduction of Biosimilar Therapeutics into Nephrology Practice in the US’ on 17–18 September 2015 [1].
Issues related to manufacturing, regulatory approval process, interchangeability, substitution/switching, nomenclature, and clinician and patient awareness and acceptance were examined. This report summarizes the main discussions at the symposium, highlights several controversies and makes recommendations related to public policy, professional and patient education and research needs.
Once biosimilar erythropoiesis stimulating agents (ESAs) are approved in the US, decisions regarding their use will be a function of cost savings versus residual safety concerns. It is likely that health plans and dialysis providers will encourage the use of biosimilar ESAs by requiring less hassle and paperwork to prescribe them versus the reference agent, so interchangeability becomes less of a driver to the use of biosimilars than formulary decisions.
If a biosimilar ESA is deemed interchangeable, then the process for substitution at the pharmacy level will vary according to state law, but all states will allow the prescriber to prevent substitution by writing ‘dispense as written’ or something to that effect. If substitution does occur it will be vital for both the prescriber and patient to be informed so that any adverse reactions can be attributed to a specific agent. Pharmacovigilance to identify patterns and trends of adverse events will require unique identifiers for each agent.
Biosimilars are a new frontier of therapy in the US and constitute a learning, research and public policy opportunity for all stakeholders. The expansion of biosimilar ESAs into the US market should answer many questions regarding their efficacy, safety and pharmacoeconomics at a level of statistical power not previously achieved. In order for this to occur, the appropriate educational, investigative and policy (at the state and Federal level) infrastructure must be in place as these agents are approved.
Conflict of interest
Several of the authors of the research paper [1] reported conflicts of interest, including having worked as a consultant, as a clinical investigator and serving on the board of directors of various pharmaceutical companies. For full details of the authors’ conflicts of interest, see the research paper [1].
Abstracted by Jay Wish of Indiana University Health, Indianapolis, Indiana.
Editor’s comment
Readers interested to learn more about biosimilars are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
Biosimilars in oncology: current and future perspectives
The ethics of biosimilars
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Reference
1. Wish JB, Charytan C, Chertow GM, Kalantar-Zadeh K, Kliger AS, Rubin RJ, et al. Introduction of biosimilar therapeutics into nephrology practice in the United States: report of a scientific workshop sponsored by the National Kidney Foundation. Am J Kidney Dis. 2016. pii: S0272-6386(16)30346-8. doi: 10.1053/j.ajkd.2016.06.022 [Epub ahead of print]
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