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Drug Products: Biologics, Biosimilars and Interchangeables01:28

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Body: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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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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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-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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Update on Biosimilar Insulins: A US Perspective.

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Biosimilar insulins are evolving in the US, but prices remain high. New regulations may increase competition, impacting patients and healthcare providers, though outcomes are uncertain.

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Area of Science:

  • Pharmacoeconomics
  • Regulatory Science
  • Endocrinology

Background:

  • Limited availability of biosimilar insulins in the US, with only two products currently approved.
  • Despite existing biosimilar options, insulin prices have not decreased significantly.
  • Patient adoption of available biosimilar insulins like Basaglar® and Admelog® has been substantial.

Purpose of the Study:

  • To review the development of biosimilar insulin products in the United States.
  • To analyze recent regulatory changes impacting biosimilar insulin approval and interchangeability.
  • To discuss the potential challenges and ramifications for patients, prescribers, and payers.

Main Methods:

  • Review of current literature on biosimilar insulin development.
  • Analysis of the Biologics Price Competition and Innovations Act and its impact on insulin regulation.
  • Discussion of clinical and economic implications of new regulatory pathways.

Main Results:

  • The US has seen slow development of biosimilar insulins, with high prices persisting.
  • New regulations effective March 2020 offer an abbreviated approval pathway and interchangeability designation for biosimilar insulins.
  • Potential for increased competition exists, but supply-chain and financial impacts are not yet clear.

Conclusions:

  • The updated regulatory landscape for biosimilar insulins presents both opportunities and uncertainties.
  • Abbreviated clinical testing may accelerate the market entry of new follow-on insulin products.
  • The full impact of these regulatory changes on healthcare costs and patient access remains to be determined.