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

353
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...
353
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

218
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...
218
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

398
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...
398
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

260
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.
260
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

244
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...
244

You might also read

Related Articles

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

Sort by
Same author

Targeting Warburg effect in Chinese hamster ovary cell culture with pyruvate dehydrogenase kinase inhibitors.

Biotechnology progress·2026
Same author

Osmolyte-Based Formulations for Enhanced Thermal Stability of mRNA Drug Substance: A Systematic Screening and Optimization Study.

Pharmaceutical research·2026
Same author

Structural Elucidation of Fc- and Fab-Associated <i>N</i>-Glycans in Cetuximab Using Protein A-Assisted Domain-Resolved Glycan Profiling Using Mass Spectrometry.

Journal of the American Society for Mass Spectrometry·2026
Same author

Bioinformatic pipeline to identify potential therapeutic targets with subsequent isolation and characterization of novel human anti- DDR1 antibodies.

Scientific reports·2026
Same author

Rapid Identification of Counterfeit Biopharmaceuticals using Portable Fourier Transform Infrared Spectroscopy.

AAPS PharmSciTech·2026
Same author

A Multitechnique Spectroscopy Platform for Monitoring Heterogeneities in the Higher-Order Structure of mAb Therapeutics.

Molecular pharmaceutics·2026

Related Experiment Video

Updated: Apr 5, 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 India.

Anurag S Rathore1

  • 1Department of Chemical Engineering, Indian Institute of Technology, Hauz Khas, New Delhi 110016, India.

Journal of Proteomics
|August 17, 2015
PubMed
Summary
This summary is machine-generated.

India has significant potential in the biosimilar market, facing challenges but leveraging proteomics for analytical comparability. This review discusses the current landscape and future prospects for biosimilar development in India.

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

18.5K
Pooled shRNA Library Screening to Identify Factors that Modulate a Drug Resistance Phenotype
14:51

Pooled shRNA Library Screening to Identify Factors that Modulate a Drug Resistance Phenotype

Published on: June 17, 2022

3.7K

Related Experiment Videos

Last Updated: Apr 5, 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
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

18.5K
Pooled shRNA Library Screening to Identify Factors that Modulate a Drug Resistance Phenotype
14:51

Pooled shRNA Library Screening to Identify Factors that Modulate a Drug Resistance Phenotype

Published on: June 17, 2022

3.7K

Area of Science:

  • Biotechnology
  • Pharmaceutical Sciences
  • Analytical Chemistry

Background:

  • Biosimilars are biotech drugs with comparable quality, safety, and efficacy to originator products.
  • The biotech industry shows increased interest in biosimilars, with regulatory pathways evolving.
  • Understanding quality attributes' impact on biosimilar safety and efficacy is advancing.

Purpose of the Study:

  • To discuss India's current status in biosimilar development and commercialization.
  • To identify major challenges faced by India in the biosimilar sector.
  • To highlight the role of proteomics in establishing biosimilar analytical comparability.

Main Methods:

  • Review of current developments in biosimilar regulation and industry interest.
  • Analysis of India's position and challenges in the global biosimilar market.
  • Discussion on the application of proteomics for biosimilar characterization.

Main Results:

  • India possesses substantial potential in the biosimilar sector.
  • Key challenges in development and commercialization exist.
  • Proteomics offers a crucial tool for analytical comparability.

Conclusions:

  • India is poised to become a significant player in the biosimilar market.
  • Addressing challenges is essential for realizing India's potential.
  • Proteomics is vital for ensuring biosimilar quality and comparability.