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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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Biopharmaceutics and Pharmacokinetics: Overview01:28

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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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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
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During the development of a new pharmaceutical, the manufacturer initially assigns a code name to the drug. Once approved, the drug receives a United States Adopted Name (USAN)—a generic, nonproprietary designation. Upon being listed in the United States Pharmacopeia, this nonproprietary name becomes the drug's official name. Additionally, the manufacturer assigns a proprietary name or trademark, which serves as the brand name under which the drug is marketed. It is worth noting that...
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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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ARE WE READY FOR MULTIPLE SWITCHES BETWEEN REFERENCE PRODUCTS AND BIOSIMILARS?

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Biosimilars offer cost savings and improve access to Inflammatory Bowel Disease (IBD) treatments. This review examines if evidence supports multiple switches between biologics and biosimilars for IBD patients.

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Area of Science:

  • Gastroenterology
  • Pharmacoeconomics
  • Immunology

Background:

  • Inflammatory Bowel Diseases (IBD) present a significant socioeconomic burden due to chronic, progressive, and incurable nature.
  • Biologic therapies, while revolutionary, incur substantial healthcare costs, limiting access and affordability.
  • Biosimilars offer a pathway to reduce costs, enhance treatment accessibility, and enable broader patient care, including new diagnoses and dose optimization.

Purpose of the Study:

  • To review existing literature on the efficacy and safety of biosimilars in Inflammatory Bowel Disease (IBD) treatment.
  • To evaluate the scientific evidence supporting multiple switches between reference biologics and biosimilars in IBD patients.
  • To discuss the implications of biosimilar use for healthcare systems and patient access to advanced therapies.

Main Methods:

  • Comprehensive literature review of randomized controlled trials and observational studies.
  • Analysis of data on efficacy, safety, and immunogenicity related to single and multiple switches.
  • Synthesis of evidence regarding the clinical and economic impact of biosimilar adoption in IBD management.

Main Results:

  • Current evidence supports the safety and efficacy of a single switch between reference biologics and biosimilars.
  • Data on the long-term outcomes and safety profiles of multiple switches in IBD patients remains limited.
  • Biosimilars demonstrate comparable effectiveness and safety to originator biologics, facilitating cost reductions.

Conclusions:

  • A single switch between biologics and biosimilars is supported by robust scientific evidence for IBD management.
  • Further research is needed to establish the safety and efficacy of multiple switches in IBD patients.
  • Increased biosimilar utilization is crucial for cost reduction and improved access to advanced IBD therapies.