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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

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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Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems01:22

Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems

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Body:Bioavailability is a critical pharmacological concept that measures the extent and rate at which an active drug ingredient or therapeutic moiety enters the systemic circulation, remaining unchanged. It's a pivotal factor in determining a drug's efficacy and safety.The Biopharmaceutics Classification System (BCS) plays an essential role in drug development by categorizing drugs into four classes based on their solubility and permeability. This classification aids in understanding drug...
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Bioavailability Enhancement: Drug Permeability Enhancement01:27

Bioavailability Enhancement: Drug Permeability Enhancement

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Body:After oral administration, poor permeability often limits the rate at which drugs are absorbed through the intestinal epithelium. Enhancing drug permeability is crucial for effective therapy, and several strategies have been developed to overcome this challenge.One effective strategy involves the use of lipid-based formulations. These formulations enhance dissolution and solubility, targeting physiological mechanisms to increase drug absorption. This includes stimulating bile salt...
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Issues And Trends In Healthcare Delivery System01:29

Issues And Trends In Healthcare Delivery System

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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.
Cost Containment
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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

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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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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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The three-fer: How biosimilars reduce cost, expand access, and improve margin.

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    Medicare patients saw a 47% reduction in reference biologic use after implementing a biosimilar-first strategy. This shift lowered costs, increased patient access, and improved financial margins for the health system.

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    Area of Science:

    • Health Economics
    • Pharmaceutical Policy
    • Quality Improvement Science

    Background:

    • Traditional Medicare Fee for Service (FFS) covers reference biologics and biosimilars without prior authorization (PA).
    • Biosimilars provide a cost-effective, safe, and effective alternative to reference biologics.

    Purpose of the Study:

    • To decrease Medicare FFS patient use of reference biologics in oncology by 50%.
    • To reduce Mayo Clinic Community Accountable Care Organization (MCC ACO) spending and achieve institutional cost savings.
    • To improve revenue by increasing the utilization of biosimilars.

    Main Methods:

    • Implemented a Quality Improvement (QI) framework to expand a biosimilar-first strategy.
    • Utilized targeted electronic health record (EHR) reports to identify Medicare patients using reference biologics when biosimilars were available.
    • Facilitated patient conversion to lower-cost, formulary-preferred biosimilars through pharmacist and physician outreach and education.

    Main Results:

    • Achieved a 47% reduction in reference biologic use among Medicare patients.
    • Decreased MCC ACO spending by $2.62 million and reduced per-utilizer-per-month spending by 13.9%.
    • Improved medication margins by over $2.2 million for a modeled patient volume of 1,000 per drug category.

    Conclusions:

    • Quality improvement initiatives effectively reduced reference biologic utilization in Medicare patients.
    • The shift to biosimilars successfully lowered healthcare spending and increased patient access.
    • The strategy improved financial margins, demonstrating the economic benefits of biosimilar adoption.