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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 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...
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,...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

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).
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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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Relevant issues to biossimilars licensing.

Beatriz Serrapio Peres1, Gabriela Padilha, Cristiane Quental

  • 1Coordenação de Propriedade Intelectual, Agência Nacional de Vigilância Sanitária, Brazil.

Revista Brasileira De Epidemiologia = Brazilian Journal of Epidemiology
|March 22, 2013
PubMed
Summary
This summary is machine-generated.

Biopharmaceuticals require specific regulations due to manufacturing complexity, unlike generics. Regulatory frameworks in Brazil, the EU, and US show similarities but differ in flexibility and economic considerations for biosimilars.

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Area of Science:

  • Biopharmaceutical regulation
  • Drug approval processes
  • Comparative regulatory analysis

Background:

  • Generic drug approval relies on extrapolating reference product data.
  • Biopharmaceuticals, large molecules, are sensitive to manufacturing changes, impacting safety and efficacy.
  • Existing generic paradigms are unsuitable for biopharmaceuticals, necessitating distinct regulatory pathways.

Purpose of the Study:

  • To survey key issues in approving similar biopharmaceutical products.
  • To compare regulatory approaches in the US and EU for biopharmaceuticals.
  • To inform the regulatory discussion in Brazil regarding biopharmaceutical approval.

Main Methods:

  • Bibliographical survey of regulatory issues.
  • Comparative analysis of US (FDA) and EU (EMEA) legislation, guidelines, and technical references.
  • Review of Brazilian regulatory landscape.

Main Results:

  • Brazil, EU, and US are developing biopharmaceutical regulatory frameworks with shared principles like case-by-case evaluation.
  • Europe adopts a more conservative stance; US and Brazil appear more flexible.
  • Interchangeability and automatic substitution remain undefined; economic factors are crucial in US/EU but not Brazil.

Conclusions:

  • Biopharmaceutical regulation requires tailored approaches, differing from generics.
  • Regulatory frameworks are evolving globally, with convergence on some principles but divergence on others.
  • Brazil's current regulation lacks economic considerations, potentially impacting market entry for producers.