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Related Concept Videos

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...
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 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...
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 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...

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Related Experiment Video

Updated: Jun 29, 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

Biosimilars: it's not as simple as cost alone.

S D Roger1, D Goldsmith

  • 1Department of Renal Medicine, Gosford Hospital, Gosford 2250, Australia. sroger@nsccahs.health.nsw.gov.au

Journal of Clinical Pharmacy and Therapeutics
|October 7, 2008
PubMed
Summary
This summary is machine-generated.

Follow-on biologics (FoB) require extensive development and testing for safety and efficacy. These rigorous processes may limit the anticipated cost-savings compared to originator biologics.

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

Related Experiment Videos

Last Updated: Jun 29, 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

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

Area of Science:

  • Biopharmaceutical development
  • Regulatory science

Background:

  • Biosimilars, or follow-on biologics (FoB), are complex protein-based drugs.
  • Unlike small molecule generics, FoB data is not directly transferable between products.
  • Regulatory bodies acknowledge that FoB require comprehensive development, precluding accelerated approval pathways.

Purpose of the Study:

  • To evaluate the economic implications of follow-on biologics.
  • To balance the costs of FoB development and market pricing against the need for guaranteed efficacy and safety.

Main Methods:

  • Analysis of developmental program requirements for follow-on biologics.
  • Assessment of pharmacovigilance costs and challenges.
  • Economic evaluation of biosimilar market entry.

Main Results:

  • Extensive testing is crucial to ensure patient safety with follow-on biologics.
  • Comprehensive development programs and robust pharmacovigilance are resource-intensive.
  • The overall cost-effectiveness of follow-on biologics may be constrained by these requirements.

Conclusions:

  • The potential cost savings from follow-on biologics might be less significant than initially projected.
  • Ensuring biosimilar safety and efficacy necessitates substantial investment.
  • Regulatory and developmental hurdles impact the economic viability of biosimilars.