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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
Drug Nomenclature01:17

Drug Nomenclature

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 the same...
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
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Bioequivalence: Overview

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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Corrigendum to: "Nursing Care of the Patient Hospitalized with Heart Failure: Executive Summary: A Scientific Statement from the American Association of Heart Failure Nurses" [Heart Lung. 64(2024).A1-A5/doi:10.1016/j.hrtlng.2024.01.008. Epub 2024 Feb 7].

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Unintended Financial Barriers: When "Generic" Does Not Mean Affordable.

Jill DiStefano, Natalie W Pierson

    Journal of Cardiac Failure
    |July 14, 2026
    PubMed
    Summary

    Generic sacubitril/valsartan for heart failure remains inaccessible for many due to persistent financial and administrative hurdles. These barriers hinder treatment adherence and worsen patient outcomes, despite the drug

    Area of Science:

    • Cardiology
    • Health Economics
    • Pharmacoeconomics

    Background:

    • Sacubitril/valsartan is a key therapy for heart failure with reduced ejection fraction (HFrEF).
    • Generic availability was intended to increase affordability and access to this vital medication.
    • Real-world data indicates persistent barriers despite generic entry.

    Purpose of the Study:

    • To examine the ongoing financial and administrative obstacles to sacubitril/valsartan access.
    • To identify factors contributing to treatment nonadherence and interruption.
    • To highlight the impact of these barriers on patient outcomes and 'financial toxicity'.

    Main Methods:

    • Analysis of real-world clinical experience with generic sacubitril/valsartan.
    • Identification of specific financial barriers (e.g., deductibles, formulary issues, copay loss).

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  • Assessment of administrative hurdles (e.g., prior authorizations, enrollment issues).

    • Main Results:

    • Financial and administrative barriers persist despite generic availability of sacubitril/valsartan.
    • High deductibles, formulary issues, and prior authorizations disrupt therapy continuity.
    • These obstacles disproportionately affect vulnerable populations, leading to nonadherence and financial toxicity.

    Conclusions:

    • Generic availability alone does not guarantee access to sacubitril/valsartan.
    • Financial toxicity is a modifiable risk factor in HFrEF management.
    • Benefit design must align with evidence-based care to ensure sustained patient access and clinical benefit.