Spanish Society of Hospital Pharmacy position paper on biosimilar 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 c...
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| Format: | Article |
| Language: | English |
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Elsevier
2018-07-01
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| Series: | Farmacia Hospitalaria |
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| Online Access: | http://www.aulamedica.es/fh/pdf/10973.pdf |
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| author | Noemí Martínez-López de Castro María Belén Matilla-Fernández María Dolores Fraga-Fuentes Irene Mangues-Bafalluy Rocío Asensi-Díez Gerardo Cajaraville-Ordoñana |
| author_facet | Noemí Martínez-López de Castro María Belén Matilla-Fernández María Dolores Fraga-Fuentes Irene Mangues-Bafalluy Rocío Asensi-Díez Gerardo Cajaraville-Ordoñana |
| author_sort | Noemí Martínez-López de Castro |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-3bd33a5db1274f48b31ea6baedeb2777 |
| institution | DOAJ |
| issn | 1130-6343 2171-8695 |
| language | English |
| publishDate | 2018-07-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Farmacia Hospitalaria |
| spelling | doaj-art-3bd33a5db1274f48b31ea6baedeb27772025-08-20T02:56:46ZengElsevierFarmacia Hospitalaria1130-63432171-86952018-07-0142418018310.7399/fh.10973Spanish Society of Hospital Pharmacy position paper on biosimilar medicinesNoemí Martínez-López de Castro0María Belén Matilla-Fernández1María Dolores Fraga-Fuentes2Irene Mangues-Bafalluy3Rocío Asensi-Díez4Gerardo Cajaraville-Ordoñana5Grupo GENESIS. Servicio de Farmacia, Complejo Hospitalario Universitario de Vigo, VigoGrupo GEDEFO. Servicio de Farmacia, Complejo Asistencial Universitario de León, León.Grupo GENESIS. Servicio de Farmacia, Hospital General La Mancha Centro, Alcázar de San Juan (Cuidad Real).Grupo GEDEFO. Servicio de Farmacia, Hospital Arnau de Vilanova de Lleida, Lleida.Grupo GENESIS. Servicio de Farmacia, Hospital Regional Universitario de Málaga, Málaga.Grupo GEDEFO. Servicio de Farmacia, Fundación ONKOLOGIKOA, San Sebastián.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.http://www.aulamedica.es/fh/pdf/10973.pdfBiosimilarsBiological medicines; SwitchingHospital pharmacist |
| spellingShingle | Noemí Martínez-López de Castro María Belén Matilla-Fernández María Dolores Fraga-Fuentes Irene Mangues-Bafalluy Rocío Asensi-Díez Gerardo Cajaraville-Ordoñana Spanish Society of Hospital Pharmacy position paper on biosimilar medicines Farmacia Hospitalaria Biosimilars Biological medicines ; Switching Hospital pharmacist |
| title | Spanish Society of Hospital Pharmacy position paper on biosimilar medicines |
| title_full | Spanish Society of Hospital Pharmacy position paper on biosimilar medicines |
| title_fullStr | Spanish Society of Hospital Pharmacy position paper on biosimilar medicines |
| title_full_unstemmed | Spanish Society of Hospital Pharmacy position paper on biosimilar medicines |
| title_short | Spanish Society of Hospital Pharmacy position paper on biosimilar medicines |
| title_sort | spanish society of hospital pharmacy position paper on biosimilar medicines |
| topic | Biosimilars Biological medicines ; Switching Hospital pharmacist |
| url | http://www.aulamedica.es/fh/pdf/10973.pdf |
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