Spanish Society of Hospital Pharmacy position paper on biosimilar medicines
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| Formato: | Artículo científico |
| Lenguaje: | en |
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Sociedad Española de Farmacia Hospitalaria
2018
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| _version_ | 1876479298293989376 |
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| author | Noemí Martínez-López de Castro |
| author_facet | Noemí Martínez-López de Castro |
| contents | Spanish Society of Hospital Pharmacy position paper on biosimilar medicines Noemí Martínez-López de Castro María Belén Matilla-Fernández María Dolores Fraga-Fuentes Irene Mangues-Bafalluy Rocío Asensi-Díez Gerardo Cajaraville-Ordoñana Grupo GENESIS Grupo GEDEFO Proyecto MAPEX Medicina Switching Biosimilars Hospital pharmacist Biological medicines Biological medicines nowadays have a great impact, as they offer treatment for diverse diseases and suppose a high cost for health system. Biosimilar medicines contain a version of an active substance already authorized as an original biotechnological medicine, whose patent has expired, and they comply with the guidelines published by the European Medicines Agency. These guidelines, where biosimilarity criteria are established, guarantee comparability between biosimilar product and reference one. Biosimilars’ authorization is carried out through a centralized procedure based on clinical, non-clinical and quality studies. These studies allow the extrapolation of indications, frequently, without carrying out additional analyses. In several European countries, switching between original and biosimilar medicine is considered safe. In Spain, Pharmacy and Therapeutic Committee of hospitals, as consensus bodies among health professionals, are the most suitable bodies to establish the interchangeability criteria in each center. Biosimilar drugs contribute to sustainability and to improvement of the accessibility to medicines. Faced with this situation, Spanish Society of Hospital Pharmacy considers interesting to express its position about biosimilar medicines’ strategies. Spanish Society of Hospital Pharmacy, in September 2015, published an information note about biosimilar medicines, in which its role as medicines similar in quality, safety and efficacy to the originals, but at lower cost, was highlighted. Likewise, it was stressed the role of hospital pharmacists within the Pharmacy and Therapeutic Committee of hospitals, where their knowledge for the selection, evaluation and use of medicines could be useful, in coordination and permanent collaboration with other units or clinical services of hospitals. 2018 artículo científico 1130-6343 https://www.redalyc.org/articulo.oa?id=365962269009 https://www.redalyc.org/journal/3659/365962269009/ https://www.redalyc.org/journal/3659/365962269009/html/ https://www.redalyc.org/journal/3659/365962269009/365962269009.epub https://www.redalyc.org/journal/3659/365962269009/movil 10.7399/fh.10973 en http://www.redalyc.org/revista.oa?id=3659 Farmacia Hospitalaria application/pdf Sociedad Española de Farmacia Hospitalaria Farmacia Hospitalaria (España) Num.4 Vol.42 |
| format | Artículo científico |
| id | redalyc_365962269009 |
| institution | Redalyc |
| language | en |
| publishDate | 2018 |
| publisher | Sociedad Española de Farmacia Hospitalaria |
| spellingShingle | Spanish Society of Hospital Pharmacy position paper on biosimilar medicines Noemí Martínez-López de Castro Medicina Switching Biosimilars Hospital pharmacist Biological medicines Spanish Society of Hospital Pharmacy position paper on biosimilar medicines Noemí Martínez-López de Castro María Belén Matilla-Fernández María Dolores Fraga-Fuentes Irene Mangues-Bafalluy Rocío Asensi-Díez Gerardo Cajaraville-Ordoñana Grupo GENESIS Grupo GEDEFO Proyecto MAPEX Medicina Switching Biosimilars Hospital pharmacist Biological medicines Biological medicines nowadays have a great impact, as they offer treatment for diverse diseases and suppose a high cost for health system. Biosimilar medicines contain a version of an active substance already authorized as an original biotechnological medicine, whose patent has expired, and they comply with the guidelines published by the European Medicines Agency. These guidelines, where biosimilarity criteria are established, guarantee comparability between biosimilar product and reference one. Biosimilars’ authorization is carried out through a centralized procedure based on clinical, non-clinical and quality studies. These studies allow the extrapolation of indications, frequently, without carrying out additional analyses. In several European countries, switching between original and biosimilar medicine is considered safe. In Spain, Pharmacy and Therapeutic Committee of hospitals, as consensus bodies among health professionals, are the most suitable bodies to establish the interchangeability criteria in each center. Biosimilar drugs contribute to sustainability and to improvement of the accessibility to medicines. Faced with this situation, Spanish Society of Hospital Pharmacy considers interesting to express its position about biosimilar medicines’ strategies. Spanish Society of Hospital Pharmacy, in September 2015, published an information note about biosimilar medicines, in which its role as medicines similar in quality, safety and efficacy to the originals, but at lower cost, was highlighted. Likewise, it was stressed the role of hospital pharmacists within the Pharmacy and Therapeutic Committee of hospitals, where their knowledge for the selection, evaluation and use of medicines could be useful, in coordination and permanent collaboration with other units or clinical services of hospitals. 2018 artículo científico 1130-6343 https://www.redalyc.org/articulo.oa?id=365962269009 https://www.redalyc.org/journal/3659/365962269009/ https://www.redalyc.org/journal/3659/365962269009/html/ https://www.redalyc.org/journal/3659/365962269009/365962269009.epub https://www.redalyc.org/journal/3659/365962269009/movil 10.7399/fh.10973 en http://www.redalyc.org/revista.oa?id=3659 Farmacia Hospitalaria application/pdf Sociedad Española de Farmacia Hospitalaria Farmacia Hospitalaria (España) Num.4 Vol.42 |
| title | Spanish Society of Hospital Pharmacy position paper on biosimilar medicines |
| topic | Medicina Switching Biosimilars Hospital pharmacist Biological medicines |
| url | https://www.redalyc.org/articulo.oa?id=365962269009 https://www.redalyc.org/journal/3659/365962269009/ https://www.redalyc.org/journal/3659/365962269009/html/ https://www.redalyc.org/journal/3659/365962269009/365962269009.epub https://www.redalyc.org/journal/3659/365962269009/movil |