Biosimilar Drug Development

Johanna Mielke () and Byron Jones ()
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Johanna Mielke: Novartis Pharma AG
Byron Jones: Novartis Pharma AG

Chapter 66 in Principles and Practice of Clinical Trials, 2022, pp 1237-1260 from Springer

Abstract: 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.

Keywords: Follow-on biologics; Equivalence testing; Totality of the evidence; Biosimilarity; Extrapolation; Biologics; Comparability; Analytics; Switchability; Historical information (search for similar items in EconPapers)
Date: 2022
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-3-319-52636-2_272

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DOI: 10.1007/978-3-319-52636-2_272

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