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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

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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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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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Production of Pharmaceuticals01:30

Production of Pharmaceuticals

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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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Incretins include glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which stimulate insulin secretion post-meals. In type 2 diabetes, GIP's efficacy is reduced, making GLP-1 a viable drug target. GIP originates from preproGIP.
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Insulin: Dosing Regimen and Adverse Effects01:16

Insulin: Dosing Regimen and Adverse Effects

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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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Biosimilar insulins: a European perspective.

J H DeVries1, S C L Gough, J Kiljanski

  • 1Endocrinology, Academic Medical Centre, Amsterdam, The Netherlands.

Diabetes, Obesity & Metabolism
|November 8, 2014
PubMed
Summary
This summary is machine-generated.

Biosimilar insulins are coming soon to Europe. This article explains biosimilarity, regulatory requirements, and clinical issues for healthcare providers to understand these new insulin options.

Keywords:
biosimilarsdiabetesinsulinregulatory requirements

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Area of Science:

  • Pharmacology
  • Biotechnology
  • Clinical Medicine

Background:

  • Biosimilar insulins are nearing clinical implementation in Europe.
  • Understanding biosimilarity and potential differences from reference products is crucial for clinicians.
  • This article addresses the need for clinician familiarity with biosimilar insulins.

Purpose of the Study:

  • To provide an overview of biosimilar insulins.
  • To explain European regulatory requirements for biosimilar drug approval.
  • To discuss safety issues and clinical considerations for biosimilar insulin use.

Main Methods:

  • Literature review of biosimilarity concepts.
  • Analysis of European Medicines Agency (EMA) guidelines for biosimilars.
  • Summary of currently approved biosimilar insulins in Europe.
  • Review of clinical literature on biosimilar insulin use.

Main Results:

  • An overview of biosimilarity is presented.
  • Key European regulatory pathways and requirements are detailed.
  • Safety considerations and potential differences are highlighted.
  • Approved biosimilar insulins in Europe and their clinical implications are summarized.

Conclusions:

  • Clinicians need to be prepared for the introduction of biosimilar insulins.
  • Familiarity with regulatory standards and clinical nuances is essential for safe and effective patient care.
  • This article serves as a guide to understanding biosimilar insulins in the European context.