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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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Biosimilar regulation in the EU.

Pekka Kurki1, Niklas Ekman

  • 1a Evaluation of medicinal products, Finnish Medicines Agency, Mannerheimintie 103b, P.O. Box 55, 00301 Helsinki, Finland.

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Summary

The European Medicines Agency (EMA) has extensive guidelines for biosimilars, enabling 21 safe and effective biosimilar medicines to gain marketing authorization in the EU. Controversial issues like immunogenicity and indication extrapolation show no safety concerns for these widely used biosimilars.

Keywords:
biosimilarsclinical trialscomparabilityextrapolationimmunogenicityinterchangeabilityregulatory

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Area of Science:

  • Regulatory Science
  • Pharmacoeconomics
  • Biopharmaceutical Development

Background:

  • The European Medicines Agency (EMA) has accumulated significant experience with biosimilars since 1998.
  • This experience is reflected in a comprehensive set of guidelines covering principles to clinical trial specifics.
  • The EU has authorized 21 biosimilars, demonstrating a robust regulatory framework.

Purpose of the Study:

  • To review the EMA's regulatory experience and guidelines concerning biosimilars.
  • To assess the safety, traceability, and key controversial issues of currently marketed biosimilars in the EU.
  • To understand the regulatory stance on immunogenicity, extrapolation, interchangeability, and substitution.

Main Methods:

  • Analysis of EMA guidelines and regulatory documents related to biosimilar development and approval.
  • Review of post-marketing safety and traceability data for biosimilars marketed in the EU.
  • Examination of scientific literature and regulatory assessments concerning immunogenicity and therapeutic indication extrapolation.

Main Results:

  • The EMA's comprehensive guidelines have facilitated the development and authorization of 21 biosimilars.
  • Marketed biosimilars in the EU exhibit a strong safety and traceability record, with no market withdrawals due to safety issues.
  • Available data on immunogenicity and extrapolation do not raise concerns among EU regulators.

Conclusions:

  • The EMA's regulatory framework effectively supports the development of safe and effective biosimilars.
  • Current biosimilars in the EU demonstrate favorable safety profiles, addressing concerns about immunogenicity and extrapolation.
  • Interchangeability and substitution policies are determined at the individual EU member state level.