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Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of clinically relevant

Bradley J Scott1, Agnes V Klein, Jian Wang

  • 1Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutics, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Health Canada, Ottawa, K1A 0K9, Canada.

Journal of Clinical Pharmacology
|June 27, 2014
PubMed

Insights

Biosimilar monoclonal antibodies are nearing patent expiry, leading to increased development. Health Canada

Area of Science:

  • Biotechnology
  • Immunology
  • Pharmacology

Background:

  • Monoclonal antibodies (mAbs) are key therapeutics for oncology and autoimmune diseases.
  • Patent expiries for originator mAbs create opportunities for biosimilar development.
  • Biosimilar mAbs have gained regulatory approval in Canada and Europe.

Purpose of the Study:

  • To review the Canadian regulatory framework for biosimilar mAb authorization.
  • To discuss clinical requirements for demonstrating biosimilarity.
  • To outline Health Canada's approach to indication extrapolation and interchangeability.

Main Methods:

  • Review of Canadian regulatory guidelines for biosimilar drug submissions.
  • Analysis of clinical assessment principles for biosimilar mAbs.
  • Discussion of Health Canada's policies on extrapolation and post-market surveillance.

Main Results:

  • Health Canada's framework for biosimilar mAb approval is detailed.
  • Clinical requirements for establishing biosimilarity are presented.
  • Health Canada's approach to indication extrapolation differs from EMA, limiting it to a subset of indications.

Conclusions:

  • The Canadian regulatory landscape for biosimilar mAbs is evolving.
  • Establishing biosimilarity requires rigorous clinical assessment.
  • Health Canada's cautious approach to indication extrapolation impacts market access for biosimilars.
Keywords:
biologicsbiosimilarsbiotechnologyclinical trialsmonoclonal antibodiesregulatory

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