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The Path Towards a Tailored Clinical Biosimilar Development.

Martin Schiestl1, Gopinath Ranganna2, Keith Watson3

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Biosimilar development has advanced significantly since 2006. Clinical studies confirm similarity in most cases, paving the way for more efficient biosimilar development without compromising safety or efficacy.

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Area of Science:

  • Biopharmaceutical development
  • Regulatory science
  • Immunology

Background:

  • Biosimilar medicinal product approvals began in 2006.
  • Scientific understanding of biosimilar development has grown substantially.
  • This review focuses on biosimilar approval programs in the European Union (EU) and United States (US) up to November 2019.

Purpose of the Study:

  • To scrutinize public information on biosimilar development programs.
  • To evaluate the contribution of clinical studies to biosimilar approval.
  • To propose a more efficient biosimilar development pathway.

Main Methods:

  • Retrospective evaluation of public data on biosimilar development programs.
  • Analysis of clinical study data for marketing authorization and licensure.
  • Review of regulatory standards in the EU and US.

Main Results:

  • 95% of biosimilar programs demonstrated confirmed similarity in comparative clinical efficacy studies.
  • Two cases (5%) showed clinical differences in immunogenicity, leading to manufacturing changes and further studies, all occurring before 2010.
  • Biosimilar candidates not approved in the EU or US were rejected for reasons other than clinical efficacy.

Conclusions:

  • Modern assays and impurity control make recurrence of immunogenicity issues unlikely.
  • A more efficient and expedited biosimilar development pathway is proposed, potentially reducing the need for routine clinical efficacy studies.
  • The proposed pathway maintains robust regulatory standards for quality, safety, and efficacy.