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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.

Mabs
|May 12, 2015
PubMed

Insights

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.

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.
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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