Biosimilar Drug Development

Living reference work entry


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.


Follow-on biologics Equivalence testing Totality of the evidence Biosimilarity Extrapolation Biologics Comparability Analytics Switchability Historical information 



The authors gratefully acknowledge the funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Sklodowska-Curie grant agreement No 633567 and from the Swiss State Secretariat for Education, Research and Innovation (SERI) under contract number 999754557. The opinions expressed and arguments employed herein do not necessarily reflect the official views of the Swiss Government.


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Authors and Affiliations

  1. 1.Novartis Pharma AGBaselSwitzerland

Section editors and affiliations

  • Babak Choodari-Oskooei
    • 1
  • Mahesh Parmar
    • 2
  1. 1.Statistician, MRC Clinical Trials Unit at UCLInstitute of Clinical Trials and MethodologyLondonUK
  2. 2.MRC Clinical Trials Unit and Institute of Clinical Trials and MethodologyUniversity College of LondonLondonEngland

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