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Regulatory frameworks for biosimilars are crucial for ensuring the safety and effectiveness of these important biologic medicines. This paper examines global biosimilar regulations, technical concepts, and international differences.

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Area of Science:

  • Biopharmaceutical science
  • Regulatory affairs
  • Pharmacoeconomics

Background:

  • Biologics are vital for treating rheumatic, autoimmune, inflammatory, and neoplastic diseases.
  • Regulations ensure the safety, quality, and effectiveness of biologics.
  • Patent expiry of originator biologics drives biosimilar development.

Purpose of the Study:

  • To analyze the global regulatory landscape for biosimilars.
  • To discuss key technical concepts in biosimilar development and approval.
  • To highlight regulatory differences across various countries.

Main Methods:

  • Comparative analysis of international regulatory guidelines.
  • Review of scientific literature and regulatory documents.
  • Examination of legal requirements for biosimilar approval worldwide.

Main Results:

  • Significant variations exist in biosimilar approval pathways globally.
  • Harmonization efforts are ongoing but challenges remain.
  • Understanding technical requirements is key for market access.

Conclusions:

  • Global biosimilar regulation is complex and evolving.
  • Regulatory harmonization is needed to facilitate patient access to affordable biologics.
  • This review provides insights into navigating international biosimilar approval processes.