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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...
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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...
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...
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...

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Related Experiment Video

Updated: Jun 18, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

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Published on: May 4, 2017

Biosimilars approval process.

Leyre Zuñiga1, Begoña Calvo

  • 1Pharmaceutical Technology Department, Faculty of Pharmacy, University of the Basque Country, Vitoria-Gasteiz, Spain.

Regulatory Toxicology and Pharmacology : RTP
|November 21, 2009
PubMed
Summary
This summary is machine-generated.

Biosimilar development requires clinical trials, unlike generic drugs. Demonstrating biosimilarity involves comprehensive quality, safety, and efficacy assessments for regulatory approval.

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Area of Science:

  • Biopharmaceutical regulatory science
  • Drug development and approval

Background:

  • Biosimilars, similar biological medicinal products, require more rigorous regulatory evaluation than generic small molecule drugs.
  • EU Directive 2001/83/EC mandates clinical trials for biological products not meeting generic drug criteria.

Purpose of the Study:

  • To outline the regulatory requirements for biosimilar approval.
  • To define the necessary non-clinical and clinical studies for biosimilar registration.
  • To emphasize the importance of a comprehensive comparability strategy.

Main Methods:

  • Assessment of EU Directive 2001/83/EC requirements for biosimilar registration.
  • Analysis of the European Medicines Agency (EMEA) dossier content for biosimilar comparability.
  • Review of strategies for demonstrating similar quality, safety, and efficacy profiles.

Main Results:

  • Biosimilar approval necessitates clinical trials, differing from generic drug bioequivalence studies.
  • The scope of non-clinical and clinical studies depends on the extent of proven comparability.
  • Dossiers must include data on immunogenicity and post-marketing pharmacovigilance.

Conclusions:

  • Regulatory approval for biosimilars hinges on demonstrating robust comparability to reference products.
  • A detailed strategy for quality, safety, and efficacy assessment is crucial for biosimilar applicants.
  • Comprehensive data, including immunogenicity and safety monitoring, is essential for successful biosimilar registration.