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Biosimilar Drug Development

In: Principles and Practice of Clinical Trials

Author

Listed:
  • Johanna Mielke

    (Novartis Pharma AG)

  • Byron Jones

    (Novartis Pharma AG)

Abstract

Biologics are innovative, complex large molecule drugs that have brought life-changing improvements to patients in various disease areas like cancer, diabetes, or psoriasis. Biosimilars are copies of innovative biologics. Their development is currently a focus of attention because the patents of several important biologics have expired, making it possible for competing companies to produce their own biosimilar version of the drug. Although, at first sight, there seems to be some similarity with the development of generics, which are copies of simple small molecule drugs, there is an important distinction because of the complexity and the variability inherent in the development of biologics. This chapter introduces the studies and analyses required to obtain regulatory approval for marketing a biosimilar and reviews several important regulatory concepts. In addition, several important statistical challenges are highlighted and discussed.

Suggested Citation

  • Johanna Mielke & Byron Jones, 2022. "Biosimilar Drug Development," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 66, pages 1237-1260, Springer.
    • Handle: RePEc:spr:sprchp:978-3-319-52636-2_272
    DOI: 10.1007/978-3-319-52636-2_272
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