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...

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,...

Bioequivalence studies: Biowaivers

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 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...

Pharmaceutical Equivalents

Pharmaceutical Equivalents

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.

Drug Biotransformation: Overview

Drug Biotransformation: Overview

Pharmaceutical substances known as xenobiotics are predominantly lipophilic and nonionized. This enables them to permeate lipid bilayers, such as cell membranes, and interact with intracellular target receptors. Lipophilic drugs have an advantage in crossing biological barriers and reaching their intended sites of action. However, lipophilic drugs often have a restricted capacity for renal expulsion or elimination from the body. When these drugs enter the kidneys and undergo glomerular...

You might also read

Related Articles

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

Sort by

Same author

Current drug therapies for rosacea: a chronic vascular and inflammatory skin disease.

Journal of managed care & specialty pharmacy·2014

Same author

A review of phosphodiesterase-inhibition and the potential role for phosphodiesterase 4-inhibitors in clinical dermatology.

Dermatology online journal·2014

Same author

Common reasons why acne patients call the office.

Dermatology online journal·2014

Same author

Improvement in severe psoriasis associated with isoniazid treatment.

Dermatology online journal·2014

Same author

Guidelines of care for the management of atopic dermatitis: section 3. Management and treatment with phototherapy and systemic agents.

Journal of the American Academy of Dermatology·2014

Same author

Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies.

Journal of the American Academy of Dermatology·2014

Search research articles

Related Experiment Video

Updated: Apr 8, 2026

Synthesis of Stimuli-responsive Nanogels using Aqueous One-step Crosslinking and Co-nanopolymerization

Synthesis of Stimuli-responsive Nanogels using Aqueous One-step Crosslinking and Co-nanopolymerization

Published on: January 24, 2025

Biologics and biosimilars.

Palak K Patel¹, Caleb R King, Steven R Feldman

¹Health Information Technology, Grady Health System , Atlanta, GA , USA .

The Journal of Dermatological Treatment

|June 25, 2015

Summary

Biosimilars offer competitive alternatives to biologic drugs, but are not exact replicas. Approving and using these complex biological medicines requires balancing cost with potential variations in clinical effects.

Keywords:

Biologics biosimilars interchangeability low-molecular weight drug manufacturing variability

More Related Videos

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

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: Apr 8, 2026

Synthesis of Stimuli-responsive Nanogels using Aqueous One-step Crosslinking and Co-nanopolymerization

Synthesis of Stimuli-responsive Nanogels using Aqueous One-step Crosslinking and Co-nanopolymerization

Published on: January 24, 2025

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

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:

Biotechnology
Pharmacology
Dermatology

Background:

Biological drugs are large, complex glycoprotein molecules produced in living organisms.
Patent expiration for innovator biologics creates opportunities for biosimilar development.
Biosimilars are highly similar but not identical to innovator biologic drugs due to inherent complexity.

Purpose of the Study:

To discuss the implications of biosimilar development in dermatology.
To address the challenges in regulating and prescribing biosimilars.
To highlight the need for careful consideration of batch variability and clinical effects.

Main Methods:

Review of existing guidelines on biosimilar approval and naming.
Analysis of the inherent batch-to-batch variability in biologic drugs.
Comparison of biosimilar data requirements with innovator product variations.

Main Results:

Biosimilars, while not identical, are designed to have similar clinical effects.
Innovator biologics also exhibit batch-to-batch variability, accepted in clinical practice.
Uncertainty exists regarding the precise clinical impact of variations in both innovator and biosimilar products.

Conclusions:

Biosimilars should be viewed as unique therapeutic interventions requiring distinct identification.
Balancing cost-effectiveness and development timelines with biological response variability is crucial for biosimilar adoption.
Physician awareness and notification are important for the safe and effective use of biosimilars.