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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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...
Bioequivalence: Overview01:16

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

Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems

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 absorption...
Biopharmaceutics and Pharmacokinetics: Overview01:28

Biopharmaceutics and Pharmacokinetics: Overview

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 appropriate...
Bioavailability: Overview01:13

Bioavailability: Overview

Bioavailability refers to the proportion of an unaltered drug that, after administration, enters the systemic circulation and can be distributed to the desired action site. Factors such as gastrointestinal (GI) absorption and liver biotransformation influence the bioavailability of a drug when it is administered orally. When a drug is administered intravenously, it enters the systemic circulation directly; by definition, its bioavailability is assumed to be 100%. The bioavailability of an...
Bioavailability: Overview01:17

Bioavailability: Overview

Bioavailability refers to the proportion of an administered drug that reaches the systemic circulation in its active, unaltered form. It is a crucial pharmacokinetic parameter that determines the effectiveness of a drug in achieving its intended therapeutic outcomes. The route of administration significantly influences bioavailability, with intravenous administration achieving 100% bioavailability as the drug directly enters the bloodstream. In contrast, oral administration often results in...

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Synthesis of Stimuli-responsive Nanogels using Aqueous One-step Crosslinking and Co-nanopolymerization
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Outcomes-based access: what will it mean for biologics?

Rachel M Renshaw

    Biotechnology Healthcare
    |February 21, 2013
    PubMed
    Summary

    Manufacturers must adapt to evolving formulary submission standards for biologic therapies. Understanding and meeting payer expectations is key for market access and third-party reimbursement.

    Area of Science:

    • Health Economics and Outcomes Research
    • Pharmaceutical Market Access
    • Biologics Therapeutics

    Background:

    • The Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions, guided by Outcome-Based Agreements (OBA), is now a widely adopted standard in the pharmaceutical industry.
    • Managed care organizations (MCOs) are increasingly applying rigorous standards, similar to those for traditional pharmaceuticals, to biologic therapies.
    • This shift necessitates a strategic response from biologic manufacturers to navigate payer requirements.

    Purpose of the Study:

    • To explore the implications of evolving formulary submission standards for biologic therapies.
    • To identify strategies for biologic manufacturers to ensure product acceptance by third-party payers.
    • To provide guidance on aligning with managed care organization expectations.

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    Main Methods:

    • Analysis of current trends in formulary management and payer requirements for biologics.
    • Review of the AMCP Format and its underlying principles.
    • Examination of successful market access strategies for innovative therapies.

    Main Results:

    • Biologic manufacturers face heightened scrutiny regarding clinical and economic value propositions.
    • Demonstrating cost-effectiveness and comparative effectiveness is crucial for formulary placement.
    • Proactive engagement with payers and transparent data submission are vital.

    Conclusions:

    • Biologic manufacturers must proactively develop robust data packages that address payer needs.
    • Adapting to the AMCP Format's principles for biologics is essential for securing third-party payer acceptance.
    • Strategic alignment with MCO standards will facilitate market access for novel biologic therapies.