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...

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).

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,...

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 indication due to...

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...

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...

You might also read

Related Articles

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

Sort by

Same author

Real-world external control arm for the single-arm LIBRETTO-001 trial of selpercatinib in RET-mutation-positive medullary thyroid cancer: RECALIB-RET.

ESMO open·2026

Same author

Clinical benefit of anti-PD-(L)1 immunotherapies in advanced cancer in France: a population-based estimate from 2014 to 2021.

ESMO open·2024

Same author

Whole exome sequencing in molecular diagnostics of cancer decreases over time: evidence from a cost analysis in the French setting.

The European journal of health economics : HEPAC : health economics in prevention and care·2021

Same author

Locally unresectable differentiated thyroid cancer: outcomes and perspectives.

Endocrine·2020

Same author

Partial versus whole breast irradiation: Side effects, patient satisfaction and costs.

Cancer radiotherapie : journal de la Societe francaise de radiotherapie oncologique·2019

Same author

Update of survival and cost of metastatic melanoma with new drugs: Estimations from the MelBase cohort.

European journal of cancer (Oxford, England : 1990)·2018

Search research articles

Related Experiment Video

Updated: Jun 13, 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 and medico-economic aspects].

I Borget¹, T Grivel

¹Institut Gustave-Roussy, Etudes et Recherche en Economie de la Santé, 39 rue Camille-Desmoulins, 94805 Villejuif cedex, France. isabelle.borget@igr.fr

Bulletin Du Cancer

|April 14, 2010

Summary

Biosimilars, copies of biotechnology drugs, may offer cost savings but face higher development hurdles than generics. Their economic impact could be less than anticipated due to stringent regulations.

Area of Science:

Biotechnology and Pharmaceutical Economics
Drug Development and Regulation

Context:

Biotechnology drugs generated $71 billion in sales in 2008, with 17% annual growth.
Patent expirations for biotechnology drugs lead to the development of biosimilars.
European Medicines Agency (EMEA) established distinct biosimilar regulations in 2004.

Purpose:

To analyze the medico-economic factors influencing biosimilar availability.
To describe the biotechnology drug market.
To compare generics and biosimilars, examining their cost implications.

Summary:

Biosimilars, distinct from generics, require extensive clinical research and post-authorization monitoring.
These regulatory requirements increase research, development, and marketing costs for biosimilars.

More Related Videos

Cost-Efficient Transcriptomic-Based Drug Screening

Cost-Efficient Transcriptomic-Based Drug Screening

Published on: February 23, 2024

Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions

Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions

Published on: December 1, 2020

Related Experiment Videos

Last Updated: Jun 13, 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

Cost-Efficient Transcriptomic-Based Drug Screening

Cost-Efficient Transcriptomic-Based Drug Screening

Published on: February 23, 2024

Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions

Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions

Published on: December 1, 2020

The expected economic benefits from biosimilars may be reduced compared to traditional generics.

Impact:

Understanding biosimilar development factors is crucial for market access and substitution.
The article provides insights into the economic viability and market dynamics of biosimilars.
This analysis informs stakeholders on the potential cost reductions and challenges associated with biosimilars.