Introduction of Biosimilar Therapeutics Into Nephrology Practice in the United States: Report of a Scientific Workshop Sponsored by the National Kidney Foundation

Abstract

Biosimilars are biologic medicines highly similar to the reference product with no meaningful clinical differences in terms of safety, purity, and potency. All biologic medicines 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 biologic agents. In 2015, the US Food and Drug Administration approved the first biosimilar agent through this pathway. Approval of additional biosimilar agents in the United States, including those used by nephrologists, is anticipated. Given the relative lack of knowledge regarding biosimilars and 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 U.S., September 17 to 18, 2015. Issues related to manufacturing, the 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.

Epoetin Biosimilars in the Treatment of Chemotherapy-Induced Anemia: 10 Years’ Experience Gained

“…The US enacted the Biologics Price Competition and Innovation Act in 2010 as part of the Patient Protection and Affordable Care Act , to clarify and expedite the approval process for biosimilar agents [ 37 ]. US Food and Drug Administration (FDA) guidance on biosimilars was slow to emerge due to debates by stakeholders over how stringent the standards for new biosimilar approvals should be and whether approved biosimilars should be used interchangeably with reference medicines [ 38 ]; final guidelines on scientific and quality considerations in demonstrating biosimilarity were issued by the FDA in 2015 [ 39 ]. Unlike in Europe, the FDA pathway includes a regulatory designation on interchangeability, which, in the US, refers to the ability to automatically substitute a medicine at the pharmacy level.…”

“…Other additional areas of debate in the US relate to naming, payment, and pharmacovigilance [ 38 ]. Under the FDA regulatory pathway, the first biosimilar product, a granulocyte colony-stimulating factor, Zarzio ® (Zarxio ® , filgrastim-sndz; Hexal AG, Germany), was approved in the US in March 2015 for all the same indications as the reference medicine, Neupogen ® [ 41 ].…”

“…Under the FDA regulatory pathway, the first biosimilar product, a granulocyte colony-stimulating factor, Zarzio ® (Zarxio ® , filgrastim-sndz; Hexal AG, Germany), was approved in the US in March 2015 for all the same indications as the reference medicine, Neupogen ® [ 41 ]. Unlike in Europe, the FDA approved filgrastim-sndz without a requirement for post-marketing studies, and a lack of post-approval monitoring may be a concern to some healthcare professionals in the US [ 38 ]. Therefore, the provision of adequate professional and patient education regarding the equivalence of biosimilars is likely to be an important factor in acceptance [ 38 ].…”

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“…Indeed, there are already many interesting and established approaches to biosimilar medicine implementation which demonstrate that just because a biosimilar medicine is licensed, does not mean that its use will be accepted by prescribers nor that all patients receiving the originator brand should be automatically switched. One such approach is whereby the American National Kidney Foundation sponsored a symposium entitled "Introduction of Biosimilar Therapeutics Into Nephrology Practice in the United States" [40]. With anticipated increase in biosimilar products in the field of nephrology, mutually accepted lack of knowledge regarding the biosimilar approval process and development, and lack of trust with respect to biosimilar medicines' safety and efficacy, this community of experts decided to meet at a nationwide level to discuss the introduction of biosimilars into their area of medicine.…”

“…With anticipated increase in biosimilar products in the field of nephrology, mutually accepted lack of knowledge regarding the biosimilar approval process and development, and lack of trust with respect to biosimilar medicines' safety and efficacy, this community of experts decided to meet at a nationwide level to discuss the introduction of biosimilars into their area of medicine. The colloquium highlighted several controversies but also made recommendations related to public policy, professional and patient education, and research needs [40]. With the introduction of new biosimilars set to increase on the market in coming years [41], this example of individual fields of medicine taking responsibility for biosimilar usage pertaining to their area may be a safe, feasible and effective approach to introduce biosimilars into the clinical setting.…”