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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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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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Bioequivalence: Overview01:16

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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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An integrated healthcare system (IHS) is a set of organizations that provides for or arranges to provide coordinated and continuous service to a defined population. The IHS takes responsibility for that particular population's health status and outcome, both clinically and fiscally. An integrated healthcare system is a well-organized, well-coordinated, and collaborative network. The integrated delivery system is a network that connects different healthcare providers to deliver organized,...
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Bioequivalence studies: Biowaivers01:13

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Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Issues And Trends In Healthcare Delivery System01:29

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The issues and trends in healthcare delivery are constantly changing. The COVID-19 pandemic is one recent issue that wreaked havoc on healthcare systems, causing a shortage of healthcare workers, high demand for medicines and supplies, and increased medical expenditure due to a lack of insurance. Other issues include rising healthcare costs and care fragmentation.
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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

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The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
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Related Experiment Video

Updated: Oct 14, 2025

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Biosimilar strategic implementation at a large health system.

Indrani Kar1, Margaret Kronz2, Evelina Kolychev3

  • 1System Pharmacy Services, University Hospitals Health System, Cleveland, OH, USA.

American Journal of Health-System Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists
|November 9, 2021
PubMed
Summary

A health system developed a strategic process for reviewing and selecting biosimilars, leading to significant cost savings and provider endorsement. This systematic approach ensures effective formulary management and operational integration of biosimilar agents.

Keywords:
biosimilarcost savingsfilgrastimhealth systeminfliximabpegfilgrastimtrastuzumab

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Area of Science:

  • Pharmacoeconomics
  • Health policy
  • Drug formulary management

Background:

  • The increasing market availability of biosimilars necessitates a structured approach for health systems to evaluate and integrate these agents.
  • Establishing clear protocols is crucial for managing the clinical, safety, and economic aspects of biosimilar adoption.
  • Proactive planning is essential to address potential barriers in electronic medical record (EMR) preparation and operational workflows.

Purpose of the Study:

  • To outline a health system's comprehensive strategy for the formulary review and selection of biosimilar products.
  • To detail the process for supporting therapeutic interchanges and ensuring safe implementation of biosimilars.
  • To establish a repeatable framework for future biosimilar evaluations and ongoing monitoring.

Main Methods:

  • Conducting thorough assessments of available literature, payor coverage, and anticipated biosimilar approvals.
  • Preparing the electronic medical record (EMR) 6-12 months in advance of formulary review.
  • Engaging multidisciplinary teams, including key departments and clinicians, to evaluate clinical, safety, and economic data.
  • Implementing preferred biosimilar products through education, formulary availability, and provider engagement.

Main Results:

  • Successful adoption of 5 preferred biosimilar products has resulted in substantial cost savings for the institution.
  • The established process has gained endorsement from healthcare providers.
  • The systematic approach effectively managed formulary, safety, and operational barriers.

Conclusions:

  • A deliberate, multidisciplinary process is key to successfully managing biosimilar integration.
  • Clear communication and stakeholder engagement are critical for achieving cost savings and provider buy-in.
  • The developed framework provides a sustainable model for ongoing biosimilar management and optimization.