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

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...
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
Bioequivalence studies: Biowaivers01:13

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...
Bioequivalence of Drugs: Drugs with Multiple Indications01:09

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: Overview01:16

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,...
Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...

You might also read

Related Articles

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

Sort by
Same author

Green hospital pharmacy: A sustainable approach to the medication use process in a tertiary hospital.

Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria·2023
Same author

Real-world experience of palbociclib and ribociclib: novel oral therapy in metastatic breast cancer.

International journal of clinical pharmacy·2020
Same author

[Platelet aggregation disorder due to amitriptyline].

Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria·2011
Same author

[Consensus document on the use of granulocyte colony stimulating factor biosimilars for correction of neutropenia in cancer patients].

Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria·2010
Same author

Vein irritation from i.v. pentamidine.

American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists·1996
Same author

Hyperglycemia induced by megestrol acetate in a patient with AIDS.

The Annals of pharmacotherapy·1996
Same journal

[Translated article] Real-world evidence of immune-related adverse events as predictive factor of response in non-small cell lung cancer.

Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria·2026
Same journal

[Translated article] Safety of excipients in pediatric medications: impact on child health.

Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria·2026
Same journal

[Translated article] Computerized gravimetric control of parenteral analgesic admixtures: A retrospective quality improvement study.

Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria·2026
Same journal

Training pathways: An educational response to an evolving hospital pharmacy specialty.

Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria·2026
Same journal

Depression, stress and medication adherence in patients with type 2 diabetes: A crosssectional study in Mexico.

Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria·2026
Same journal

[Translated article] Cutting-edge healthcare and Hospital Pharmacy.

Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria·2026
See all related articles

Related Experiment Video

Updated: Jun 8, 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

[Biosimilars: regulatory status for approval].

A Herrero Ambrosio1

  • 1Servicio de Farmacia, Hospital Universitario La Paz, Madrid, España.

Farmacia Hospitalaria : Organo Oficial De Expresion Cientifica De La Sociedad Espanola De Farmacia Hospitalaria
|October 6, 2010
PubMed
Summary
This summary is machine-generated.

Biosimilar medicines, copies of biotech drugs, offer future medical treatments. Approved by the European Medicines Evaluation Agency (EMEA), they meet high standards for quality, efficacy, and safety.

More Related Videos

A Validatable Droplet Digital Polymerase Chain Reaction Assay for the Detection of Adeno-Associated Viral Vectors in Bioshedding Studies of Tears
07:43

A Validatable Droplet Digital Polymerase Chain Reaction Assay for the Detection of Adeno-Associated Viral Vectors in Bioshedding Studies of Tears

Published on: July 14, 2023

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

Related Experiment Videos

Last Updated: Jun 8, 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

A Validatable Droplet Digital Polymerase Chain Reaction Assay for the Detection of Adeno-Associated Viral Vectors in Bioshedding Studies of Tears
07:43

A Validatable Droplet Digital Polymerase Chain Reaction Assay for the Detection of Adeno-Associated Viral Vectors in Bioshedding Studies of Tears

Published on: July 14, 2023

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

Area of Science:

  • Biotechnology and Pharmaceutical Sciences
  • Drug Development and Regulation

Context:

  • Biotechnological drugs are advancing medical treatments.
  • Patent expirations allow for the development of biosimilar medicines.
  • The European Medicines Evaluation Agency (EMEA) regulates biosimilar approval.

Purpose:

  • To explain the regulatory framework and scientific standards for biosimilar drug approval.
  • To define biosimilar medicines and their relationship to originator biotech drugs.

Summary:

  • Biosimilar medicines are highly similar to approved biologic medicines, demonstrating no clinically meaningful differences in terms of safety and efficacy.
  • The EMEA mandates rigorous preclinical and clinical studies to ensure the quality, efficacy, and patient safety of biosimilar products.
  • The World Health Organization (WHO) supports that biosimilar products share the same International Nonproprietary Name (INN) as their reference product.

Impact:

  • Biosimilars increase patient access to advanced biologic therapies.
  • Competition from biosimilars can lead to reduced healthcare costs.
  • The stringent regulatory process ensures the güvenilirliği (reliability) and effectiveness of biosimilar medicines in clinical practice.