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Related Concept Videos

Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
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 Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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...
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 of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

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 indication due to...

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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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Biosimilar Use Among 38 ASCO PracticeNET Practices, 2019-2021.

Brian Bourbeau1, Gary H Lyman2,3, Xiudong Jennifer Lei1

  • 1American Society of Clinical Oncology, Alexandria, VA.

JCO Oncology Practice
|April 21, 2023
PubMed
Summary
This summary is machine-generated.

Oncology biosimilar use increased significantly from 2019-2021, lowering drug costs. However, use varied by practice type and payer, indicating further opportunities for adoption.

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Area of Science:

  • Health Economics
  • Oncology
  • Pharmacoeconomics

Background:

  • Biosimilars offer patient choice and cost savings over originator biologics.
  • Understanding biosimilar adoption in oncology is crucial for healthcare cost management.

Purpose of the Study:

  • To analyze oncology biosimilar utilization trends in US physician practices.
  • To determine the impact of practice type and payment source on biosimilar use.

Main Methods:

  • Utilized 3 years of biologic utilization data (2019-2021) from 38 US physician practices.
  • Focused on six key biologics: bevacizumab, epoetin alfa, filgrastim, pegfilgrastim, rituximab, and trastuzumab.
  • Employed logistic regression and practice surveys to identify factors influencing biosimilar adoption.

Main Results:

  • Biosimilar use increased, reaching 51%-80% of doses by late 2021.
  • Independent practices showed higher biosimilar use for certain biologics.
  • Medicaid and traditional Medicare plans exhibited lower biosimilar use compared to commercial plans.
  • Average costs per dose decreased by 24%-41%.

Conclusions:

  • Increased biosimilar use has demonstrably lowered biologic costs.
  • Biosimilar adoption varies significantly by biologic, practice type, and payer.
  • Opportunities exist to further increase biosimilar use across specific practice settings and among certain payers.