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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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...
Insulin Formulations: Types and Delivery01:27

Insulin Formulations: Types and Delivery

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.
Short-acting insulins are divided into rapid-acting...
Insulin: Biosynthesis, Chemistry, and Preparation01:25

Insulin: Biosynthesis, Chemistry, and Preparation

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.
Damage or functional impairment of β-cells inhibits insulin production, leading to diabetes. Diabetes treatment primarily uses...
Glucagon-like Receptor Agonists01:24

Glucagon-like Receptor Agonists

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.
GLP-1, when administered in high doses intravenously, triggers insulin secretion, inhibits glucagon release, slows gastric emptying, reduces food intake, and restores normal insulin secretion. However, its rapid inactivation by the...
Oral Hypoglycemic Agents: Glinides01:06

Oral Hypoglycemic Agents: Glinides

Repaglinide (Prandin) and Nateglinide (Starlix), known as glinides, are oral insulin secretagogues that stimulate insulin release from pancreatic β cells by closing the ATP-sensitive potassium channels (KATP channel). Repaglinide controls insulin release from pancreatic β cells by managing potassium efflux. It shares two binding sites with sulfonylureas and also has a unique site, indicating overlapping mechanisms of action. With a rapid onset and a 4-7 hour duration, it effectively manages...
Production of Pharmaceuticals01:30

Production of Pharmaceuticals

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 sterile, tightly...

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Intra-Omental Islet Transplantation Using h-Omental Matrix Islet filliNG (hOMING)
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Biosimilar insulins.

Lutz Heinemann1

  • 1Science & Co., Kehler Str. 24, 40468 Düsseldorf, Germany. l.heinemann@science-co.com

Expert Opinion on Biological Therapy
|May 16, 2012
PubMed
Summary

Biosimilar insulins (BIs) manufactured using modern methods are expected to enter regulated markets soon. Ensuring their safety and efficacy requires a rigorous, evidence-based approval process due to manufacturing variations.

Area of Science:

  • Biotechnology
  • Pharmaceutical Sciences
  • Regulatory Affairs

Background:

  • Insulin manufacturing is dominated by a few multinational corporations.
  • Patent expirations and advanced biotechnological methods enable new manufacturers, particularly in India and China, to produce insulin.
  • This creates opportunities for biosimilar insulins (BIs) in highly regulated markets.

Purpose of the Study:

  • To discuss the scientific and regulatory complexities of biosimilar insulin approval and usage.
  • To examine potential differences in manufacturing processes and their clinical relevance.
  • To evaluate the current regulatory landscape for biosimilar insulins in the EU and US.

Main Methods:

  • Review of existing EU guidelines for biosimilar market approval.

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Sustained Administration of β-cell Mitogens to Intact Mouse Islets Ex Vivo Using Biodegradable Poly(lactic-co-glycolic acid) Microspheres

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  • Analysis of recently issued US guidelines for biosimilars (not specific to insulin).
  • Discussion of scientific considerations regarding structural and purity differences in biosimilar insulins.

    • Main Results:

    • Manufacturing processes for insulins are not identical, leading to variations between biosimilar and originator insulins.
    • EU guidelines require demonstration of similar safety and efficacy profiles for market approval.
    • US guidelines for biosimilars do not yet specifically cover insulin.

    Conclusions:

    • Potential safety and efficacy issues with biosimilar insulins are significant and necessitate careful, evidence-driven approval.
    • Despite challenges, biosimilar insulins are likely to enter highly regulated markets in the coming years.
    • A thorough regulatory process is crucial to ensure patient safety and therapeutic equivalence.