Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

311
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...
311
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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

208
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,...
208
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

332
Body: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...
332
Bioequivalence: Overview01:16

Bioequivalence: Overview

2.1K
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,...
2.1K

You might also read

Related Articles

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

Sort by
Same author

Physicochemical characterization of ferric carboxymaltose and iron sucrose nanoparticles in human plasma: stability and nanoparticle-protein complex formation.

Journal of colloid and interface science·2026
Same author

The scientific controversy is essential.

Annales pharmaceutiques francaises·2026
Same author

The CArbapenem sparing antimicrobial stewardship project: an innovative approach to reduce carbapenem consumption in low-users hospital settings.

The Journal of hospital infection·2026
Same author

Recommendations on Drug Selection and Dose Adjustment for Patients with Liver Cirrhosis: Results from a Multidisciplinary Expert Panel.

Clinical drug investigation·2026
Same author

Stability Assessment of Intravenous Iron-Carbohydrate Complexes in Commercial All-in-One Parenteral Nutrition: Potential for Therapeutic Iron Dose Admixing.

Pharmaceutics·2026
Same author

Sulfide silver autometallography to differentiate the ultrastructural localization of iron-carbohydrate complexes inside macrophages.

Scientific reports·2025
Same journal

Multiomics Profiling During Autoimmune Demyelination Highlights a Complex Regulatory Role for Ataxin-1 in B Cells.

Annals of the New York Academy of Sciences·2026
Same journal

Global Trends in Light Pollution and Their Relationship With Socioeconomic Factors.

Annals of the New York Academy of Sciences·2026
Same journal

Wired for Corruption: Inter-Brain Synchrony Encodes Bribery-Related Value Information and Predicts Bribery Agreement.

Annals of the New York Academy of Sciences·2026
Same journal

LM-YOLO: A Lightweight Multi-Scale Enhanced Model for Forest Smoke Detection Using Unmanned Aerial Vehicles.

Annals of the New York Academy of Sciences·2026
Same journal

Polyrhythm Perception and Production: A Scoping Review.

Annals of the New York Academy of Sciences·2026
Same journal

DARTS-CNN-BiLSTM: Intelligent Fault Diagnosis for Computer Numerical Control Machine Tool Feed System.

Annals of the New York Academy of Sciences·2026
See all related articles

Related Experiment Video

Updated: Feb 26, 2026

A Comprehensive Procedure to Evaluate the In Vivo Performance of Cancer Nanomedicines
07:59

A Comprehensive Procedure to Evaluate the In Vivo Performance of Cancer Nanomedicines

Published on: March 4, 2017

9.5K

How to select a nanosimilar.

Alain Astier1, Amy Barton Pai2, Marco Bissig3

  • 1Department of Pharmacy, Henri Mondor University Hospitals, Créteil, France.

Annals of the New York Academy of Sciences
|July 18, 2017
PubMed
Summary
This summary is machine-generated.

Clinically relevant differences exist between nanomedicines and nanosimilars, necessitating careful evaluation. This article offers a tool with seven criteria for pharmacists to assess nanomedicine interchangeability and substitutability.

Keywords:
hospital formularyinterchangenanomedicinesnanosimilarssubstitution

More Related Videos

Synthesis of Stimuli-responsive Nanogels using Aqueous One-step Crosslinking and Co-nanopolymerization
06:26

Synthesis of Stimuli-responsive Nanogels using Aqueous One-step Crosslinking and Co-nanopolymerization

Published on: January 24, 2025

2.0K
Selection of Transporter-Targeted Inhibitory Nanobodies by Solid-Supported-Membrane SSM-Based Electrophysiology
09:12

Selection of Transporter-Targeted Inhibitory Nanobodies by Solid-Supported-Membrane SSM-Based Electrophysiology

Published on: May 3, 2021

3.0K

Related Experiment Videos

Last Updated: Feb 26, 2026

A Comprehensive Procedure to Evaluate the In Vivo Performance of Cancer Nanomedicines
07:59

A Comprehensive Procedure to Evaluate the In Vivo Performance of Cancer Nanomedicines

Published on: March 4, 2017

9.5K
Synthesis of Stimuli-responsive Nanogels using Aqueous One-step Crosslinking and Co-nanopolymerization
06:26

Synthesis of Stimuli-responsive Nanogels using Aqueous One-step Crosslinking and Co-nanopolymerization

Published on: January 24, 2025

2.0K
Selection of Transporter-Targeted Inhibitory Nanobodies by Solid-Supported-Membrane SSM-Based Electrophysiology
09:12

Selection of Transporter-Targeted Inhibitory Nanobodies by Solid-Supported-Membrane SSM-Based Electrophysiology

Published on: May 3, 2021

3.0K

Area of Science:

  • Pharmaceutical Sciences
  • Nanotechnology in Medicine
  • Drug Regulation and Policy

Background:

  • The increasing availability of nanomedicines, including nonbiological complex drugs (NBCDs), presents challenges for healthcare providers.
  • The emergence of nanosimilars raises concerns about potential clinical differences compared to reference products, despite generic approval pathways.
  • Healthcare professionals require guidance to understand and manage these clinical variances effectively.

Purpose of the Study:

  • To provide a decision-making tool for hospital formulary inclusion of nanomedicines.
  • To establish defined criteria for evaluating the substitutability or interchangeability of nanomedicines and nanosimilars.
  • To inform healthcare professionals about clinically relevant variances in nanomedicines.

Main Methods:

  • Conducted a roundtable discussion with an international panel of experts.
  • Developed a decision-making tool based on established processes for biologicals/biosimilars.
  • Identified seven specific criteria for evaluating nanosimilars, in addition to existing biosimilar criteria.

Main Results:

  • Seven specific criteria for nanosimilar evaluation were identified: particle size and distribution, surface characteristics, uncaptured moiety fraction, storage stability, bioactive moiety uptake and distribution, and ready-to-use preparation stability.
  • The developed tool aims to support rational decision-making regarding nanomedicine formulary inclusion.
  • Pharmacists are encouraged to use these criteria to assess drug comparability for interchangeability or substitutability decisions.

Conclusions:

  • A structured approach and specific criteria are essential for evaluating nanomedicines and nanosimilars.
  • Pharmacists play a crucial role in applying pharmaceutical expertise to ensure safe and effective nanomedicine use.
  • Informed decision-making regarding nanomedicine substitutability is vital for patient care and formulary management.