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

357
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...
357
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
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
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 studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

412
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...
412
Clinical Applications of Epidermal Stem Cells01:19

Clinical Applications of Epidermal Stem Cells

3.4K
Epidermal stem cells (EpiSCs) are mainly located at the basal layer of the epidermis. These cells repair minor injuries of the skin and replace dead skin cells. However, EpiSCs’ cannot heal severe wounds such as major burns or those from diabetes or hereditary disorders. In such cases, culturing the epidermal stem cells from the patient is possible and has yielded successful treatment options, such as laboratory-grown skin grafts. These grafts are synthesized using a patient’s own...
3.4K

You might also read

Related Articles

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

Sort by
Same author

Safety and Efficacy of Bimekizumab in Patients With Moderate-to-Severe Hidradenitis Suppurativa: A Multicenter Retrospective Cohort Study.

Actas dermo-sifiliograficas·2025
Same author

Co-occurrence of Dowling-Degos Disease and Hidradenitis Suppurativa: An Exploratory Study.

Actas dermo-sifiliograficas·2025
Same author

Interobserver Variability in the Histopathological Evaluation of Melanoma: Analysis of 60 Cases.

Actas dermo-sifiliograficas·2025
Same author

[Translated article] Spanish Hidradenitis Suppurativa Registry (REHS) of the Spanish Academy of Dermatology and Venereology: Description and Data From its First Year of Operation.

Actas dermo-sifiliograficas·2025
Same author

Spanish Hidradenitis Suppurativa Registry (REHS) of the Spanish Academy of Dermatology and Venereology: description and data from its first year of operation.

Actas dermo-sifiliograficas·2025
Same author

International consensus statement on the use of ultrasound in hidradenitis suppurativa.

Journal of the European Academy of Dermatology and Venereology : JEADV·2025
Same journal

Fingolimod-associated lymphomatoid papulosis.

Actas dermo-sifiliograficas·2026
Same journal

Demodicosis: update and treatment with laser and other light sources.

Actas dermo-sifiliograficas·2026
Same journal

New treatments for adult female acne.

Actas dermo-sifiliograficas·2026
Same journal

First regulations of the Spanish Society of Dermatology (1909).

Actas dermo-sifiliograficas·2026
Same journal

Long-hair FUE: advantages and disadvantages of the most recent technique in hair transplantation.

Actas dermo-sifiliograficas·2026
Same journal

Sunburns, Tanning, and Social Media: A Descriptive Study Among Spanish University Students.

Actas dermo-sifiliograficas·2026
See all related articles

Related Experiment Video

Updated: Apr 12, 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

Biosimilars in Dermatology: Current Situation (Part I).

L Puig1, G Carretero2, E Daudén3

  • 1Servicio de Dermatología, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, España.

Actas Dermo-Sifiliograficas
|May 20, 2015
PubMed
Summary
This summary is machine-generated.

The first infliximab biosimilar for psoriasis is now available in Spain, signaling economic shifts and changes in dermatologist prescribing. Future biosimilars promise comparable efficacy and safety, supporting healthcare sustainability.

Keywords:
AdalimumabBiologicBiológicoBiosimilarClinical trialsEnsayos clínicosEtanerceptInfliximabIntercambiabilidadInterchangeabilityLegislaciónLegislationPsoriasisSubstitutionSustitución

More Related Videos

Visualizing and Quantifying Pharmaceutical Compounds within Skin using Coherent Raman Scattering Imaging
11:07

Visualizing and Quantifying Pharmaceutical Compounds within Skin using Coherent Raman Scattering Imaging

Published on: November 24, 2021

3.4K
Cultivating a Three-dimensional Reconstructed Human Epidermis at a Large Scale
08:49

Cultivating a Three-dimensional Reconstructed Human Epidermis at a Large Scale

Published on: May 28, 2021

13.6K

Related Experiment Videos

Last Updated: Apr 12, 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
Visualizing and Quantifying Pharmaceutical Compounds within Skin using Coherent Raman Scattering Imaging
11:07

Visualizing and Quantifying Pharmaceutical Compounds within Skin using Coherent Raman Scattering Imaging

Published on: November 24, 2021

3.4K
Cultivating a Three-dimensional Reconstructed Human Epidermis at a Large Scale
08:49

Cultivating a Three-dimensional Reconstructed Human Epidermis at a Large Scale

Published on: May 28, 2021

13.6K

Area of Science:

  • Dermatology
  • Pharmacoeconomics
  • Regulatory Science

Background:

  • The introduction of the first biosimilar infliximab in Spain marks a significant development in psoriasis treatment.
  • The increasing number of biosimilars is expected to impact market dynamics and clinical practice among dermatologists.

Purpose of the Study:

  • To review the regulatory landscape for biosimilar approval in the European Union.
  • To examine analytical characterization, clinical trial considerations, and contentious issues like indication extrapolation and substitution for biosimilars.
  • To assess the pipeline of upcoming psoriasis biosimilars and their potential impact on efficacy, safety, and healthcare system sustainability.

Main Methods:

  • Review of regulatory guidelines and scientific literature pertaining to biosimilars.
  • Analysis of analytical characterization and clinical trial designs for biosimilar development.
  • Examination of economic implications and prescribing pattern shifts associated with biosimilar market entry.

Main Results:

  • The European Union has a defined regulatory pathway for biosimilar approval.
  • Key considerations for biosimilars include rigorous analytical studies and specific clinical trial designs.
  • Issues such as extrapolation of indications and automatic substitution remain subjects of ongoing discussion.

Conclusions:

  • Biosimilars, including those for psoriasis, offer a pathway to potentially reduce healthcare costs while maintaining therapeutic equivalence.
  • Careful regulatory oversight and scientific evaluation are crucial for ensuring the safety and efficacy of biosimilars.
  • The integration of biosimilars is poised to enhance the sustainability of public healthcare systems.