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      Looking to the future of organ-on-chip and toxicity assessment: a regulator's opinion

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      Future Science OA
      Future Science Ltd
      organ-on-chip, pharmacology, regulation, toxicology

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          David R Jones talks to Francesca Lake, Managing Editor: David R Jones is an Expert Pharmaco-Toxicologist within the Licensing Division of the Medicines and Healthcare products Regulatory Agency. We met him at the Organ-on-a-chip Europe 2016 conference in Cambridge (UK), where he presented ‘A UK Regulatory View on the Acceptability of Organ on a Chip Data’.

          Most cited references2

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          ‘Organs-on-chips’ go mainstream

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            Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges

            ABSTRACT Biosimilars are biological medicinal products that contain a version of the active substance of an already authorised original biological medicinal product (the innovator or reference product). The first approved biosimilar medicines were small proteins, and more recently biosimilar versions of innovator monoclonal antibody (mAb) drugs have entered development as patents on these more complex proteins expire. In September 2013, the first biosimilar mAb, infliximab, was authorised in Europe. In March 2015, the first biosimilar (Zarxio™, filgrastim-sndz, Sandoz) was approved by the US Food and Drug Administration; however, to date no mAb biosimilars have been approved in the US. There are currently major differences between how biosimilars are regulated in different parts of the world, leading to substantial variability in the amount of in vivo nonclinical toxicity testing required to support clinical development and marketing of biosimilars. There are approximately 30 national and international guidelines on biosimilar development and this number is growing. The European Union's guidance describes an approach that enables biosimilars to enter clinical trials based on robust in vitro data alone; in contrast, the World Health Organization's guidance is interpreted globally to mean in vivo toxicity studies are mandatory. We reviewed our own experience working in the global regulatory environment, surveyed current practice, determined drivers for nonclinical in vivo studies with biosimilar mAbs and shared data on practice and study design for 25 marketed and as yet unmarketed biosimilar mAbs that have been in development in the past 5y. These data showed a variety of nonclinical in vivo approaches, and also demonstrated the practical challenges faced in obtaining regulatory approval for clinical trials based on in vitro data alone. The majority of reasons for carrying out nonclinical in vivo studies were not based on scientific rationale, and therefore the authors have made recommendations for a data-driven approach to the toxicological assessment of mAb biosimilars that minimises unnecessary use of animals and can be used across all regions of the world.

              Author and article information

              Future Sci OA
              Future Sci OA
              Future Science OA
              Future Science Ltd (London, UK )
              December 2016
              19 October 2016
              : 2
              : 4
              : FSO153
              [1 ]Medicines & Healthcare Products Regulatory Agency, 151 Buckingham Palace Road, London, SW1W 9SZ, UK
              Author notes
              *Author for correspondence: David.Jones@ 123456mhra.gsi.gov.uk
              © David R Jones

              This work is licensed under a Creative Commons Attribution 4.0 License

              : 22 September 2016

              organ-on-chip, pharmacology, regulation, toxicology


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