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DLC supports a defined pathway for bio-similars that puts patient welfare at the center of the process

October 26, 2015

National Diabetes Volunteer Leadership Council (DLC) Comments regarding Draft Guidance for Industry on Non-proprietary Naming of Biological Products (FDA-2013-D-1543)

  • The DLC supports a defined pathway for bio-similars that puts patient welfare at the center of the process.
  • The Burden for Interchangeability Goes Beyond Bio-similarity
  • Interchangeability requires a significantly higher testing standard than bio-similarity.
  • Interchangeability should not be permitted without complete and robust clinical data, including switching studies necessary to demonstrate that the new agent has the same clinical effect within various populations and for every indication.
  • Extrapolation of Indications Should be Approached with Great Caution
  • Extrapolation of safety or effectiveness data for one indication to support a proposed biosimilar’s approval for a different indication should be approached with caution.
  • A biosimilar is only similar and not identical to the innovator biologic. Without appropriate clinical trials, the risk/benefit profile of a biosimilar is unknown and extrapolation could therefore lead to incorrect assumptions of safety and efficacy.
  • Healthcare professionals are in the best position to make treatment decisions for their patients


For Example: (Diabetes/ Insulin & Insulin analogues)

  • Use of rapid- and long-acting insulin analogues has been shown to be beneficial in allowing patients with diabetes to safely achieve and sustain good glycemic control; however, many public and private healthcare insurers are questioning whether the added benefits of insulin analogues outweigh the additional costs.
  • Given the significant and growing pandemic of diabetes, it is imperative that healthcare resources be efficiently allocated to ensure patients receive the best possible care.
  • The availability of biosimilar insulins can potentially lead to lower insulin costs and increased access for patients with diabetes, worldwide.
  • However, because the structural properties of the proteins used in biosimilar medications are generally more complex than generic medications, it is unlikely that they will be shown to be identical to their reference products.
  • The DLC supports use of distinguishable non-proprietary names to support effective pharmacovigilance and facilitate accurate communication between patients, clinicians and pharmacists, thereby ensuring patient safety.

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