Primati e anticorpi monoclonali

[P J K van Meer, M Kooijman, J W van der Laan, E H M Moors & H Schellekens. The value of non-human primates in the development of monoclonal antibodies. Nat Biotechnol. 2013 Oct;31(10):882-3.]

Full Text: https://www.tipharma.com/fileadmin/user_upload/Theses/PDF/Peter_van_Meer_T6-301.pdf

Abstract:

Non-human primates (NHP) are often assumed to be the only relevant species to evaluate safety and efficacy of monoclonal antibodies (MAbs). However the scientific value of NHP in their development has never been established. Using drug registration files of all MAbs marketed in the European Union, we studied the value of using NHP to evaluate the safety and efficacy of these products. Inadequate justification of NHP use and ineffective study design led to a needless increase of NHP use. Immunogenicity further limited the value of NHP. As a predictive model NHP do not stand out because MAbs only exert their expected pharmacological action. Nevertheless, their use continues to increase. Therefore, a reevaluation of the need for routine studies with NHP to develop MAbs is urgently needed.

Nel testo:

”In conclusion, the value of extensive NHP use in routine safety and efficacy studies for the non-clinical assessment of MAbs is scientifically debatable and may, in that way, also miss a moral basis. Incentives for pharmaceutical companies to develop biotech products without the use of animals may help in facilitating the much needed innovation in non-clinical drug development. Dialogue between pharmaceutical industry and regulatory authorities on non-clinical requirements should be increased. More importantly however, an in depth reevaluation of the value of NHP in all stages of drug development, including products which did not reach the market, is long overdue.”

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