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

189
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...
189
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

167
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...
167
Bioequivalence: Overview01:16

Bioequivalence: Overview

1.6K
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,...
1.6K
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

113
Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
113
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

345
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,...
345
Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems01:22

Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems

118
Body:Bioavailability is a critical pharmacological concept that measures the extent and rate at which an active drug ingredient or therapeutic moiety enters the systemic circulation, remaining unchanged. It's a pivotal factor in determining a drug's efficacy and safety.The Biopharmaceutics Classification System (BCS) plays an essential role in drug development by categorizing drugs into four classes based on their solubility and permeability. This classification aids in understanding drug...
118

You might also read

Related Articles

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

Sort by
Same authorSame journal

Joint Clinical Assessment in the EU HTA Regulation-Would Drugs Supported by Single-Arm Trials Fit Under Evaluation?

Journal of market access & health policy·2026
Same author

Between Rigor and Relevance: Why the EU HTA Guidelines on Indirect Comparisons Miss the Mark.

Journal of market access & health policy·2026
Same authorSame journal

EU-HTA-Why Do Words Matter?

Journal of market access & health policy·2026
Same author

When Do Annuity-Based Payments Help to Address the Affordability Challenge of Funding Advanced Therapies? Insights from a Budget Impact Simulation.

Journal of market access & health policy·2026
Same author

Toward Regulatory Convergence and Streamlined Biosimilar Development: Recommendations from an International Qualitative Study.

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy·2025
Same author

Barriers to adoption of biosimilar insulins in Europe: A mixed-methods study.

Diabetes, obesity & metabolism·2025

Related Experiment Video

Updated: Dec 29, 2025

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

18.1K

Tendering and biosimilars: what role for value-added services?

Steven Simoens1, Raymond Cheung2

  • 1Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.

Journal of Market Access & Health Policy
|February 1, 2020
PubMed
Summary
This summary is machine-generated.

Tendering for biosimilars in Europe often prioritizes cost over value-added services (VAS). More standardized tender criteria are needed to ensure biosimilar competition and sustainability.

Keywords:
Biosimilarinfliximabsustainabilitytenderingvalue-added services

More Related Videos

Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices
06:34

Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices

Published on: November 29, 2024

523
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

1.7K

Related Experiment Videos

Last Updated: Dec 29, 2025

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

18.1K
Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices
06:34

Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices

Published on: November 29, 2024

523
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

1.7K

Area of Science:

  • Pharmacoeconomics and Health Policy
  • Biopharmaceutical Market Access

Background:

  • European health authorities utilize tendering processes for biologic medicines, including biosimilars.
  • Overemphasis on treatment costs in tenders may jeopardize biosimilar market competition and long-term viability.

Purpose of the Study:

  • To evaluate the extent and impact of incorporating value-added services (VAS) into biosimilar tendering.
  • To review existing literature on VAS inclusion in European biosimilar procurement.

Main Methods:

  • Conducted a narrative review of published literature.
  • Analyzed survey-based publications on biosimilar tendering practices.

Main Results:

  • Tendering for biosimilars is common, with cost predominantly influencing tender awards.
  • Limited information is available on non-cost criteria in tender evaluations.
  • Examples of VAS inclusion were identified for infliximab tenders, such as therapeutic drug monitoring and specific biomarker assessments.

Conclusions:

  • There is a scarcity of published data on the inclusion of VAS in biosimilar tendering.
  • Standardized tender assessment criteria could foster competition, ensure biosimilar sustainability, and maximize healthcare benefits.