Search research articles

ABOUT JoVE

Overview Leadership Blog JoVE Help Center

AUTHORS

Publishing Process Editorial Board Scope & Policies Peer Review FAQ Submit

LIBRARIANS

Testimonials Subscriptions Access Resources Library Advisory Board FAQ

RESEARCH

JoVE Journal Methods Collections JoVE Encyclopedia of Experiments Archive

EDUCATION

JoVE Core JoVE Business JoVE Science Education JoVE Lab Manual Faculty Resource Center Faculty Site

Terms & Conditions of Use

Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables

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 Indications

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...

Bioequivalence studies: Biowaivers

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...

Bioequivalence: Overview

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 Patients

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,...

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

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,...

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by

Same author

Development and formative evaluation of patient research partner involvement in a multi-disciplinary European translational research project.

Research involvement and engagement·2020

Same author

I Would Never Take Preventive Medication! Perspectives and Information Needs of People Who Underwent Predictive Tests for Rheumatoid Arthritis.

Arthritis care & research·2019

Same author

Patient involvement in a qualitative meta-synthesis: lessons learnt.

Research involvement and engagement·2017

Same author

2016 update of the EULAR recommendations for the management of early arthritis.

Annals of the rheumatic diseases·2016

Search research articles

Related Experiment Video

Updated: Mar 30, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

Published on: May 4, 2017

Biosimilars: what do patients need to consider?

|November 5, 2015

Summary

This summary is machine-generated.

Patients can consider several issues regarding biosimilars when discussing treatment options with their rheumatologist. More accessible information on biosimilars is needed for patients to make informed decisions.

Keywords:

Arthritis DMARDs (biologic)Patient perspective

More Related Videos

Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management

Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management

Published on: November 30, 2022

Digital Home-Monitoring of Patients after Kidney Transplantation: The MACCS Platform

Digital Home-Monitoring of Patients after Kidney Transplantation: The MACCS Platform

Published on: April 12, 2021

Related Experiment Videos

Last Updated: Mar 30, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

Published on: May 4, 2017

Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management

Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management

Published on: November 30, 2022

Digital Home-Monitoring of Patients after Kidney Transplantation: The MACCS Platform

Digital Home-Monitoring of Patients after Kidney Transplantation: The MACCS Platform

Published on: April 12, 2021

Area of Science:

Rheumatology
Pharmacology

Background:

Biosimilars offer alternatives to originator biologic medicines for rheumatic diseases.
Shared decision-making is crucial for effective patient-centered care.

Purpose of the Study:

To outline key considerations for patients regarding biosimilars in rheumatology.
To highlight the need for improved patient information on biosimilars.

Main Methods:

Expert opinion from the EULAR Standing Committee of People with Arthritis/Rheumatism in Europe (SCPARE).
Review of patient-relevant issues concerning biosimilar adoption.

Main Results:

Identified patient considerations for biosimilar discussions with rheumatologists.
Emphasized the necessity of lay-language resources for biosimilar information.

Conclusions:

Patients should be informed about biosimilars to facilitate shared decision-making.
Enhanced availability of understandable information on biosimilars is essential for European patients with rheumatic conditions.