Multiple Source Biosimilar Insulin, What's a Provider to Do?

Abstract

In the United States the FDA designates generic products that are bioequivalent as AB substitutable (FDA rating signifying the approved application contains adequate scientific evidence establishing through in vivo and/or in vitro studies the bioequivalence of the product to a selected reference product) and are expected to produce the same therapeutic results as the innovator product. In the case of biological proteins that are similar to already approved innovator biologicals, such as recombinant human insulin, the insulin molecule and accompanying secondary and tertiary structures will differ between manufacturing sources. Even subtle differences between innovator (branded) and alternative "biosimilar" products may produce different therapeutic endpoints. Substitution of a branded insulin with a biosimilar insulin product may result in more, less, or equal therapeutic response making in difficult for the practitioner to assess glycemic control between patient follow-up visits. Significant therapeutic difference is possible, which could result in mild to severe hypoglycemia reaction or hyperglycemia induced tissue damage. Slight molecular changes along with different accompanying proteins, protein fragments, and other naturally occurring contaminants theoretically increase odds of insulin resistance or allergic reaction. Current review of medication product and device quality relies on manufacturer self-oversight and individual reporting of product adverse events after use. While this is usually sufficient for oral medications and many medical devices, critical use products such as sterile products, biosimilar insulin, insulin delivery devices, self-monitoring blood glucose monitoring systems, and test strips require much more vigorous oversight to prevent individual and/or large scale catastrophe. Health care providers should advocate for their patient to have access to affordable, consistent, quality-assured products to effectively and safely manage their medical issues. A potential commonsense solution would be to utilize existing nonprofit organizations with access to pharmacy/laboratory services that have vested interest in ensuring product quality throughout the supply pipeline. The old adage "an ounce of prevention is worth a pound of cure" holds even more true in today's medical environment.