Table 3.

Key biosimilar issues of concern to nephrologists (25)

Key Biosimilar Issues of Concern
Naming of biosimilars
 Minimize inadvertent substitution
 Maintain pharmacovigilance
 Use of shared core name
 Unique four-letter suffix, devoid of meaning, for each product (including interchangeable products)
Interchangeability
 No sponsor of a biosimilar product has yet requested an interchangeable designation
 A single transition from a reference product to a noninterchangeable biosimilar may be appropriate on the basis of the prescriber’s clinical judgment
 Substitution of a biosimilar for an originator biologic without the prescriber’s consent can occur only for an interchangeable biologic (see below)
Substitution
 According to the FDA, interchangeable products may be substituted for the reference product without the intervention of the prescribing health care provider
 Many states have enacted legislation establishing standards for substitution of biosimilar product to replace the reference biologic
 The NKF recommends that patients also be informed of such substitutions by pharmacists, health insurance plans, hospitals, infusion centers, and dialysis care providers
 The NKF recommends that when a biosimilar has an established safety record for 5 yr prescribers no longer be routinely informed of such substitutions
Extrapolation
 Has not yet been a major issue since registration trials for the first biosimilar with application to nephrology patients (epoetin) were performed in patients with CKD
 Extrapolation of indications applies only to FDA-approved uses of the reference biologic, which may (e.g., eculizumab, basiliximab) or may not (e.g., rituximab) include a nephrology indication
Education for providers and patients
 Advantages and disadvantages of biosimilars when compared with the reference product
 Known and unknown risks of the biosimilar versus the reference product
 Extent of clinical experience with the biosimilar versus the reference product
 How cost of the product affects its selection
Research and pharmacovigilance
 Initial period of postmarketing surveillance for the safety of newly approved biosimilars in the United States should be in the range of 2–4 yr
 Additional long-term research will be needed regarding the safety and efficacy of biosimilar agents in general and products in particular
  “Hard” outcomes (e.g., hospitalizations, mortality, rate of CKD progression, transplant survival)
  Intermediate outcomes (e.g., cardiovascular events, blood counts, chemistries, inflammatory markers, BP, carcinogenesis, immunogenesis)
  Efficacy data (blood transfusions, iron requirements, hemoglobin levels, and drug doses in the case of erythropoietins)
  Patient-reported outcomes (quality of life, clarity of information presented, and thoughts and beliefs regarding biosimilars)
  • FDA, Food and Drug Administration; NKF, National Kidney Foundation.