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Related Concept Videos

Bioequivalence: Overview01:16

Bioequivalence: Overview

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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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Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
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Prodrugs are a class of pharmaceutical compounds that undergo a biotransformation process within the body to be converted into a pharmacologically active drug. Prodrugs are designed to improve the therapeutic properties of the parent drug, such as enhancing bioavailability, increasing stability, or reducing toxicity. The concept of prodrugs revolves around modifying the chemical structure of the original drug to make it more effective or convenient for administration.
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Related Experiment Video

Updated: Jul 5, 2025

Laboratory Scale Production and Purification of a Therapeutic Antibody
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Biosimilars: From Production to Patient.

Maria Sheridan1,2,3,4, Matthew Massich1,2,3,4, Nazanin Ashourian1,2,3,4

  • 1Fresenius Kabi USA, LLC, Lake Zurich, Illinois.

Journal of Infusion Nursing : the Official Publication of the Infusion Nurses Society
|January 11, 2024
PubMed
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Biosimilars offer a safe and effective alternative to reference biologics, increasing patient access and reducing healthcare costs. Increased prescriber and patient knowledge is crucial for wider adoption and maximizing benefits.

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Area of Science:

  • Biotechnology and Pharmaceutical Sciences
  • Pharmacoeconomics
  • Clinical Pharmacology

Background:

  • Biologic drugs are complex molecules produced via biotechnology.
  • Biosimilars are highly similar to approved reference biologics, sharing no clinically meaningful differences in safety, purity, or efficacy.
  • The US FDA established an abbreviated approval pathway (351[k]) for biosimilars in 2009.

Purpose of the Study:

  • To review the evidence supporting biosimilar safety and efficacy.
  • To discuss the impact of biosimilars on patient access and healthcare costs.
  • To highlight the importance of education for healthcare professionals and patients regarding biosimilars.

Main Methods:

  • Review of existing clinical trial data and real-world evidence on biosimilar switching.
  • Analysis of economic projections for biosimilar cost savings.
  • Discussion of factors influencing biosimilar adoption, including prescriber confidence and patient education.

Main Results:

  • Strong evidence indicates switching to biosimilars does not compromise treatment effectiveness or increase adverse events.
  • Biosimilar utilization in the US is rising, with projected cost savings of $104 billion between 2020-2024.
  • Increased knowledge among healthcare professionals and patients is needed to enhance biosimilar acceptance.

Conclusions:

  • Biosimilars present a valuable opportunity to reduce healthcare costs and expand access to biologic therapies.
  • Prescriber confidence and patient education are essential to overcome the nocebo effect and ensure successful biosimilar integration.
  • Infusion nurses play a key role in patient education and improving clinical outcomes with biosimilars.