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Related Concept Videos

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,...
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...
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...
Pharmaceutical Equivalents01:26

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.
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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...

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Related Experiment Video

Updated: Jul 14, 2026

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

Why Biosimilars Can Never Be Identical To Originators-and Why They Don't Need To Be.

Thomas Reinke

    Managed Care (Langhorne, Pa.)
    |March 19, 2019
    PubMed
    Summary

    Biosimilar approval requires high similarity to original biologics, but this "no clinically meaningful differences" standard may increase perceived risk for clinicians and patients.

    Area of Science:

    • Biopharmaceutical science
    • Regulatory science

    Background:

    • The U.S. Food and Drug Administration (FDA) mandates biosimilars demonstrate high similarity to reference biologic products.
    • Current FDA approval criteria focus on establishing "no clinically meaningful differences" between biosimilars and their originators.

    Purpose of the Study:

    • To analyze the implications of the FDA's current approval standards for biosimilars.
    • To explore the perception of risk associated with biosimilars among clinicians and patients.

    Main Methods:

    • Review of FDA regulatory guidelines for biosimilar approval.
    • Analysis of clinical and patient perspectives on biosimilar safety and efficacy.

    Main Results:

    • The "highly similar" and "no clinically meaningful differences" criteria may inadvertently heighten concerns.
    Keywords:
    Biosimilar PharmaceuticalsUnited States Food and Drug Administration

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    Last Updated: Jul 14, 2026

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  • Perceived risk for biosimilars can exceed that of original biologics due to similarity alone.

    • Conclusions:

    • Current FDA approval language for biosimilars may not fully alleviate clinician and patient concerns.
    • Revisiting regulatory communication could potentially mitigate perceived risks and improve biosimilar adoption.