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Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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The endoplasmic reticulum (ER) of pancreatic β-cells synthesizes preproinsulin, which consists of a signal peptide, A and B chains, and a C-peptide. Preproinsulin is then cleaved and folded into proinsulin, which translocates to the Golgi apparatus for sorting and packaging into secretory granules. In these granules, enzymatic clipping generates insulin and C-peptide.
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Industrial insulin production uses genetically engineered E. coli expressing a proinsulin gene controlled by a tryptophan promoter and containing a methionine linker for later cleavage. The cells also carry ampicillin resistance for selective growth. Seed cultures are stored at −80 °C and production begins by thawing a small amount to inoculate starter cultures, which are progressively scaled to a 50,000-L bioreactor. In the bioreactor, E. coli grow in nutrient-rich media under...
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Insulin preparations are categorized by their duration of action into short-acting and long-acting types. Two strategies are used to modify insulin's absorption and pharmacokinetic profile: slowing the absorption post-subcutaneous injection, or altering human insulin's amino acid sequence or protein structure. These changes retain the insulin's ability to bind to the insulin receptor, but alter its behavior in solution or after injection.
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Insulin-replacement therapy usually includes both long-acting insulin (basal) and short-acting insulin (to cater to postprandial needs). In a diverse group of type 1 diabetes patients, the average daily insulin dose is typically 0.5-0.7 units/kg body weight. However, obese patients and pubertal adolescents may need more due to insulin resistance.
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In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Multiple Source Biosimilar Insulin, What's a Provider to Do?

Alan Carter1

  • 1University of Missouri-Kansas City School of Pharmacy, Kansas City, MO, USA acarter@mriglobal.org.

Journal of Diabetes Science and Technology
|May 31, 2014
PubMed
Summary

Biosimilar insulins may differ from branded versions, potentially causing varied therapeutic effects and risks. Enhanced oversight is crucial for ensuring the safety and quality of these critical biological products.

Keywords:
MedicaidMedicarebioengineeredbioequivalentbiosimilar insulinchronic diseasecontaminantscostdevicesfinancialformularyinsurancequalitysafetytherapeutic

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Area of Science:

  • Pharmacology
  • Biotechnology
  • Regulatory Science

Background:

  • The U.S. FDA designates bioequivalent generic products as AB substitutable, expecting identical therapeutic results to innovator products.
  • Biological proteins like recombinant human insulin can exhibit molecular and structural differences between manufacturing sources, even if similar to innovator products.
  • Subtle variations in biosimilar insulins may lead to different therapeutic outcomes compared to branded versions.

Purpose of the Study:

  • To highlight potential therapeutic discrepancies between innovator and biosimilar insulin products.
  • To underscore the need for more rigorous oversight of critical medical products, including biosimilar insulins.
  • To advocate for healthcare providers to ensure patient access to safe, affordable, and quality-assured medical products.

Main Methods:

  • Review of FDA designations for generic and biosimilar products.
  • Analysis of potential molecular and structural differences in biological proteins.
  • Evaluation of current quality oversight mechanisms for medical products.

Main Results:

  • Differences in insulin molecules and accompanying structures between manufacturing sources can lead to varied therapeutic endpoints.
  • Substitution of branded insulin with biosimilars may result in unpredictable glycemic control, increasing risks of hypoglycemia or hyperglycemia.
  • Current self-oversight and post-market adverse event reporting may be insufficient for critical products like biosimilar insulin.

Conclusions:

  • Vigorous oversight is essential for critical use products such as biosimilar insulin to prevent adverse events.
  • Healthcare providers must champion patient access to consistent, quality-assured, and affordable medical products.
  • Collaborating with nonprofit organizations for supply chain quality assurance offers a commonsense preventative solution.