Search research articles

ABOUT JoVE

Overview Leadership Blog JoVE Help Center

AUTHORS

Publishing Process Editorial Board Scope & Policies Peer Review FAQ Submit

LIBRARIANS

Testimonials Subscriptions Access Resources Library Advisory Board FAQ

RESEARCH

JoVE Journal Methods Collections JoVE Encyclopedia of Experiments Archive

EDUCATION

JoVE Core JoVE Business JoVE Science Education JoVE Lab Manual Faculty Resource Center Faculty Site

Terms & Conditions of Use

Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables

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...

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).

Microorganisms in Medicine and Therapeutics

Microorganisms in Medicine and Therapeutics

Microorganisms play a fundamental role in vaccine development, gene therapy, and therapeutic production. Their biological properties are harnessed to advance medicine and public health. Beyond immunization, microorganisms contribute to gut health, antibiotic synthesis, and genetic disease treatment.Live Attenuated and Inactivated VaccinesLive attenuated vaccines, such as the measles, mumps, and rubella (MMR) vaccine, utilize weakened forms of pathogens to closely resemble natural infections.

Bioequivalence: Overview

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,...

Biopharmaceutical Factors Influencing Drug Product Design: Overview

Biopharmaceutical Factors Influencing Drug Product Design: Overview

Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...

Bioequivalence of Drugs: Drugs with Multiple Indications

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...

You might also read

Related Articles

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

Sort by

Same author

The Epididymis: An Ultrasound Primer-What the Radiologist Needs to Know.

Abdominal radiology (New York)·2025

Same author

SGLT2 inhibitors: a promising new therapeutic option for treatment of type 2 diabetes mellitus.

The Journal of pharmacy and pharmacology·2013

Same author

Obesity pharmacotherapy: current perspectives and future directions.

Current cardiology reviews·2012

Same author

Alloxan: an unpredictable drug for diabetes induction?

Indian journal of pharmacology·2012

Same author

Breast abscess after nipple piercing: sonographic findings with clinical correlation.

Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine·2011

Same author

Spectrum of imaging findings in the silicone-injected breast.

Plastic and reconstructive surgery·2011

Search research articles

Related Experiment Video

Updated: May 24, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

Published on: May 4, 2017

Biosimilars: current perspectives and future implications.

¹Department of Pharmacology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India. drmonikamisra@gmail.com

Indian Journal of Pharmacology

|February 21, 2012

Summary

This summary is machine-generated.

Biosimilars are not biological generics due to manufacturing complexities. This article explores biosimilar differences, safety concerns, and regulatory needs for these unique biological products.

Keywords:

Biopharmaceuticals biosimilars generic drugs

More Related Videos

BioMEMS and Cellular Biology: Perspectives and Applications

BioMEMS and Cellular Biology: Perspectives and Applications

Published on: October 1, 2007

Laboratory Scale Production and Purification of a Therapeutic Antibody

Laboratory Scale Production and Purification of a Therapeutic Antibody

Published on: January 24, 2017

Related Experiment Videos

Last Updated: May 24, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

Published on: May 4, 2017

BioMEMS and Cellular Biology: Perspectives and Applications

BioMEMS and Cellular Biology: Perspectives and Applications

Published on: October 1, 2007

Laboratory Scale Production and Purification of a Therapeutic Antibody

Laboratory Scale Production and Purification of a Therapeutic Antibody

Published on: January 24, 2017

Area of Science:

Biopharmaceutical Science
Regulatory Affairs

Background:

Biosimilars are biological products highly similar to innovator biopharmaceuticals, developed post-patent expiration.
Unlike chemical generics, biosimilars are unique molecules with limited initial approval data, raising safety and efficacy questions.

Purpose of the Study:

To differentiate biosimilars from chemical generics.
To examine concerns regarding biosimilar safety and efficacy.
To highlight the necessity for appropriate biosimilar approval regulations.

Main Methods:

Comparative analysis of biosimilar and chemical generic characteristics.
Review of existing literature on biosimilar safety and efficacy data.
Examination of regulatory frameworks for biosimilar approval.

Main Results:

Biosimilars possess distinct structural and manufacturing complexities compared to chemical generics.
Limited initial data for biosimilars necessitates careful consideration of safety and efficacy.
The unique nature of biosimilars demands specific regulatory pathways.

Conclusions:

Biosimilars should not be equated with biological generics due to inherent complexities.
Addressing safety and efficacy concerns is crucial for biosimilar adoption.
Robust and specific regulatory guidelines are essential for approving biosimilars.