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

360
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...
360
Bioequivalence: Overview01:16

Bioequivalence: Overview

2.3K
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,...
2.3K
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

267
As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
267
Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

219
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...
219
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

414
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...
414
Equivalence: In Vitro and In Vivo Bioequivalence01:17

Equivalence: In Vitro and In Vivo Bioequivalence

369
Bioequivalence studies are crucial in evaluating whether new drugs can match an approved one regarding pharmacological effects and clinical performance. These studies test if drugs, despite different dosage forms, share identical plasma concentration-time profiles. Three types of equivalence are central to these studies: chemical, pharmaceutical, and therapeutic. Chemical equivalence indicates that two or more drug products contain identical active ingredients in equal amounts. Pharmaceutical...
369

You might also read

Related Articles

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

Sort by
Same author

Follitropin alfa biosimilars: unfounded doubts on the road to reproductive care.

Human reproduction (Oxford, England)·2025
Same author

An Educational Digital Tool to Improve the Implementation of Switching to a Biosimilar (Rapid Switch Trainer): Tool Development and Validation Study.

JMIR formative research·2024
Same author

Transgenic mice overexpressing the PGE<sub>2</sub> receptor EP<sub>2</sub> on mast cells exhibit a protective phenotype in a model of allergic asthma.

Allergy·2021
Same author

<i>In Vitro</i> and <i>In Vivo</i> Validation of EP2-Receptor Agonism to Selectively Achieve Inhibition of Mast Cell Activity.

Allergy, asthma & immunology research·2020
Same author

Biosimilar and interchangeable: Inseparable scientific concepts?

British journal of clinical pharmacology·2019
Same author

Biosimilars: A Value Proposition.

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy·2019
Same journal

N-acetylcysteine for non-paracetamol-induced acute liver failure in children: A systematic review and meta-analysis.

British journal of clinical pharmacology·2026
Same journal

Anti-seizure medications and DRESS in paediatric patients: A FAERS disproportionality and time-to-onset analysis.

British journal of clinical pharmacology·2026
Same journal

Modelling immune gene expression profiles as pharmacodynamic endpoints of antileishmanial treatment.

British journal of clinical pharmacology·2026
Same journal

The effect of mild and moderate hepatic impairment on the pharmacokinetics, safety and tolerability of balcinrenone.

British journal of clinical pharmacology·2026
Same journal

Relationship between continuous infusion meropenem PK/PD target attainment and C-reactive protein dynamics in onco-haematologic patients with febrile neutropenia.

British journal of clinical pharmacology·2026
Same journal

UGT1A1 genotype testing for irinotecan: A guideline developed by the UK Centre of Excellence in Regulatory Science and Innovation in Pharmacogenomics (CERSI-PGx).

British journal of clinical pharmacology·2026
See all related articles

Related Experiment Video

Updated: Apr 15, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

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

Published on: May 4, 2017

18.3K

Biosimilar: what it is not.

Fernando de Mora1

  • 1Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Barcelona, Spain.

British Journal of Clinical Pharmacology
|April 14, 2015
PubMed
Summary
This summary is machine-generated.

Biosimilars are high-quality biological medicines proven similar to original products. Understanding what biosimilars are not, such as generics or biobetters, is crucial for proper management and patient benefit.

Keywords:
biobetterbiologicbiosimilarbiotechnology-derived medicinegenericnon-original biologic

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

2.1K
Laboratory Scale Production and Purification of a Therapeutic Antibody
09:54

Laboratory Scale Production and Purification of a Therapeutic Antibody

Published on: January 24, 2017

18.5K

Related Experiment Videos

Last Updated: Apr 15, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

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

Published on: May 4, 2017

18.3K
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

2.1K
Laboratory Scale Production and Purification of a Therapeutic Antibody
09:54

Laboratory Scale Production and Purification of a Therapeutic Antibody

Published on: January 24, 2017

18.5K

Area of Science:

  • Pharmaceutical Science
  • Regulatory Science
  • Biotechnology

Background:

  • Biosimilars are high-quality biological medicines demonstrating essential similarity to original products.
  • The European Medicines Agency (EMA) established a regulatory framework for biosimilar development, defining biosimilarity through evidence-based studies.
  • Despite regulatory clarity, misconceptions persist among healthcare professionals regarding biosimilar authorization and scientific evidence.

Purpose of the Study:

  • To address and clarify common misconceptions surrounding biosimilars.
  • To differentiate biosimilars from other product categories like generics, original biologics, and biobetters.
  • To emphasize the importance of correct therapeutic, commercial, and healthcare policy management of biosimilars.

Main Methods:

  • Conceptual analysis of biosimilar regulatory pathways.
  • Comparative review of biosimilar definitions and regulatory standards.
  • Identification and discussion of misconceptions regarding biosimilar classification and management.

Main Results:

  • Biosimilars are distinct from generics, original biologics, and biobetters, requiring specific management approaches.
  • A significant regulatory gap exists globally, allowing the market entry of non-original biologics (NOBs).
  • Misconceptions hinder the full therapeutic and economic value of biosimilars.

Conclusions:

  • Clarifying the distinct nature of biosimilars is essential for building trust among healthcare professionals.
  • Proper understanding and management of biosimilars are vital for maximizing their therapeutic benefits for patients.
  • Harmonizing global regulatory standards for biosimilars is necessary to prevent the proliferation of non-comparable products.