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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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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...
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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

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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...
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Bioequivalence: Overview01:16

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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,...
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

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Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Regulatory considerations in oncologic biosimilar drug development.

Judith C Macdonald1, Helen Hartman, Ira A Jacobs

  • 1a Pfizer Ltd. ; Tadworth , Surrey , UK.

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PubMed
Summary

Biosimilar monoclonal antibodies offer new cancer treatment options. Understanding global regulatory pathways ensures access to safe, high-quality therapies for patients with solid tumors and hematologic malignancies.

Keywords:
ADR, adverse drug reactionASBM, Alliance for Safe Biologic MedicinesCBER, US Center for Biologics Evaluation and ResearchCDER, US Center for Drug Evaluation and ResearchEBE, European Biopharmaceutical EnterprisesEMA, European Medicines AgencyEPAR, European Public Assessment ReportFDA, US Food and Drug AdministrationINN, International Non-proprietary NameSEB, subsequent entry biologicSmpC, Summary of Product CharacteristicsWHO, World Health OrganizationbiologicsbiosimilarsinterchangeabilitylabelingmAbs, monoclonal antibodiesnamingregulatory

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Area of Science:

  • Oncology
  • Immunology
  • Pharmacology

Background:

  • Biosimilar monoclonal antibodies are increasingly developed for solid tumors and hematologic malignancies.
  • Regulatory submissions for these therapies are rising globally, potentially improving patient access.
  • Stakeholder understanding of regulatory processes is crucial for identifying high-quality biosimilars.

Purpose of the Study:

  • To review global regulatory pathways for biosimilar monoclonal antibody approval.
  • To facilitate stakeholder understanding of approval criteria and international differences.
  • To promote the identification of safe and effective biosimilar treatments.

Main Methods:

  • Review of global regulatory agency guidelines and approval criteria for biosimilar monoclonal antibodies.
  • Comparative analysis of regulatory pathways in different countries.
  • Synthesis of information for various stakeholders including physicians, patients, and payers.

Main Results:

  • Significant global development and regulatory submissions for biosimilar monoclonal antibodies are occurring.
  • Variations exist in regulatory pathways and approval criteria across different countries.
  • Key areas for future guidance include labeling, naming, substitution, and indication extrapolation.

Conclusions:

  • Understanding diverse regulatory landscapes is essential for ensuring the quality, safety, and efficacy of biosimilar monoclonal antibodies.
  • Harmonization and clear guidance on biosimilar use will optimize their integration into clinical practice.
  • Enhanced stakeholder education is vital for the appropriate clinical application of these novel therapies.