Related Experiment Video
Updated: Apr 4, 2026
06:09
An In Ovo Model for Testing Insulin-mimetic Compounds
Published on: April 23, 2018
11.2K
BIOSIMILARS AND NEW INSULIN VERSIONS
Summary
New insulin versions and biosimilars are entering the market. Understanding manufacturing, regulatory pathways, and clinical use implications is crucial for healthcare providers when selecting biologic products.
Area of Science:
- Pharmacology and Therapeutics
- Biotechnology
- Regulatory Science
Background:
- Patent expirations for biologics, including insulins, are enabling new market entrants.
- The landscape of biologic therapeutics is expanding with biosimilars and novel insulin formulations.
Purpose of the Study:
- To offer clinicians a comprehensive overview of available similar biologic products in the U.S.
- To elucidate key issues surrounding manufacturing, regulatory pathways, and clinical implications of these products.
Main Methods:
- A thorough review of pertinent clinical and regulatory literature was conducted.
Main Results:
- Similar biologic products, including new insulin versions, face complex development and approval processes, often utilizing distinct regulatory pathways (e.g., 351(k) biosimilar pathway, 505(b)(2) pathway).
- Manufacturing variations can impact immunogenicity, safety, and efficacy.
- Healthcare providers must grasp concepts like interchangeability, therapeutic equivalence, and switching for new insulin products.
Conclusions:
- Understanding the nuances of similar biologic products is essential for informed decision-making by physicians, payers, and patients.
- Navigating the evolving market of biologics requires awareness of regulatory differences and clinical considerations.
Related Concept Videos
01:28Drug Products: Biologics, Biosimilars and Interchangeables
352
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...
352
01:25Insulin: Biosynthesis, Chemistry, and Preparation
2.0K
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...
Damage or functional impairment of β-cells inhibits insulin production, leading to diabetes. Diabetes treatment...
2.0K
01:27Insulin Formulations: Types and Delivery
1.1K
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...
Short-acting insulins are divided into...
1.1K
01:24Glucagon-like Receptor Agonists
1.3K
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...
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...
1.3K
01:06Oral Hypoglycemic Agents: Glinides
961
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...
961
01:30Production of Pharmaceuticals
64
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...
64