Maintaining ‘standards’ for biosimilar monoclonal antibodies
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Acknowledgements
The authors wish to thank the Scientific Advice, Human Medicines Research & Support Division from the EMA for providing the information on the Scientific Advice procedures used in Supplementary Fig. 1. This paper is based on independent research commissioned and funded by the NIHR Policy Research Programme (NIBSC Regulatory Science Research Unit). The views expressed in the publication are those of the author(s) and not necessarily those of the NHS, the NIHR, the Department of Health, ‘arms-length’ bodies or other government departments.
The National Institute for Biological Standards and Control (NIBSC) is a center of the Medicines and Healthcare Products Regulatory Agency, an Agency of the UK Government’s Department of Health and Social Care. It fulfills its public health role through the standardization and control of biologicals used in medicine. NIBSC’s strategy includes anticipating emerging quality and safety issues associated with existing and future biological medicines, and facilitation of the development of novel biological medicines and diagnostics. In some instances, it is appropriate for NIBSC to charge commercial and other organizations for its products and services, in line with guidance issued from Her Majesty’s Treasury (‘Fees & Charges Guide’ and ‘Selling into Wider Markets’). NIBSC endeavors to make the same products and services equally available to commercial organizations, without prejudice.
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