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

367
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...
367
Bioequivalence: Overview01:16

Bioequivalence: Overview

2.2K
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,...
2.2K
Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

230
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...
230
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

429
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...
429
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

270
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.
270
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

257
Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
257

You might also read

Related Articles

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

Sort by
Same author

Commentary on "Cardioprotective Effects of Dapagliflozin against Isoproterenol-induced Myocardial Injury in Rats: Biochemical and Histopathological Evidence".

International journal of applied & basic medical research·2026
Same author

Impact of vibration on human body ergonomics: Analyzing the influence of mass, cushion materials, and backrest angles using FEM.

Work (Reading, Mass.)·2025
Same author

Orientation effect and locational variation in elastic-plastic compressive properties of bovine cortical bone.

Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine·2025
Same author

Neoadjuvant vidutolimod and nivolumab in high-risk resectable melanoma: A prospective phase II trial.

Cancer cell·2024
Same author

A comprehensive review of apigenin a dietary flavonoid: biological sources, nutraceutical prospects, chemistry and pharmacological insights and health benefits.

Critical reviews in food science and nutrition·2024
Same author

Authors' response.

The Indian journal of medical research·2023
Same journal

Pityriasis Lichenoides et Varioliformis Acuta: Diagnostic Enigma Unveiled with Clinicopathologic Insights into a Rare Dermatologic Entity.

International journal of applied & basic medical research·2026
Same journal

Association of Melanocortin-4 Receptor Single Nucleotide Polymorphisms rs2331841 and rs12970134 with Metabolically Unhealthy Obesity in a North Indian Cohort.

International journal of applied & basic medical research·2026
Same journal

Assessment of Psychiatric Morbidity and Its Association with Marital Satisfaction and Quality of Life in Spouses of Patients with Alcohol Use Disorders.

International journal of applied & basic medical research·2026
Same journal

Real-world Effectiveness and Safety of Brentuximab Vedotin: A Retrospective Cohort Study from a Tertiary Care Hospital.

International journal of applied & basic medical research·2026
Same journal

Baseline Assessment of Antimicrobial Use and Stewardship Gaps in a Tertiary Care Hospital in South India: A Point Prevalence Audit.

International journal of applied & basic medical research·2026
Same journal

Effects of Mirror Therapy on Hand Function in Children with Spastic Cerebral Palsy: A Systematic Review and Meta-analysis.

International journal of applied & basic medical research·2026
See all related articles

Related Experiment Video

Updated: Apr 25, 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

17.0K

Biosimilar drugs: Current status.

Rajiv Kumar1, Jagjit Singh1

  • 1Department of Pharmacology, GMCH, Chandigarh, India.

International Journal of Applied & Basic Medical Research
|August 22, 2014
PubMed
Summary
This summary is machine-generated.

Biosimilars are similar biological products, not identical to reference drugs, posing unique regulatory challenges. Development requires careful review of therapeutic status and guidelines for safe market entry.

Keywords:
BiologicalsEuropean Medicines AgencyFood Drug AdministrationIndiabiosimilarsguidelines

More Related Videos

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

16.9K
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

1.9K

Related Experiment Videos

Last Updated: Apr 25, 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

17.0K
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

16.9K
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

1.9K

Area of Science:

  • Biotechnology
  • Pharmaceutical Sciences
  • Regulatory Affairs

Background:

  • Biologic products have seen extensive development over three decades.
  • Patent expirations for biologics have spurred the creation of biosimilars (UK) or follow-on biologics (USA).

Purpose of the Study:

  • To review the literature on biosimilar drugs.
  • To cover their therapeutic status and regulatory guidelines.

Main Methods:

  • Literature appraisal of peer-reviewed English articles.
  • Searches conducted via PubMed.
  • Review of guidelines from European Medicines Agency (EMA), US Food Drug Administration (FDA), and India.

Main Results:

  • Biosimilars are comparable but not identical to reference products; they are not generic versions and do not guarantee therapeutic equivalence.
  • Biosimilars present greater challenges than conventional generics, with more complex marketing approval processes.
  • The US enacted the Biologics Price Competition and Innovation Act of 2009, establishing an abbreviated approval pathway.
  • EMA and US FDA have established detailed scientific and approval standards.
  • India's 'Draft Guidelines on Similar Biologics' (2012) highlight the need for stringent regulations in a key manufacturing hub.

Conclusions:

  • Biosimilars require distinct regulatory frameworks compared to generics.
  • Harmonized and stringent guidelines are crucial for ensuring biosimilar safety and efficacy globally.
  • India's evolving regulatory landscape necessitates robust safety and approval standards for biosimilar manufacturing.