Details

Autor(en) / Beteiligte

• Martínez-López de Castro, Noemí
• Matilla-Fernández, María Belén
• Fraga-Fuentes, María Dolores
• Mangues-Bafalluy, Irene
• Asensi-Díez, Rocío
• Cajaraville-Ordoñana, Gerardo

Titel

Spanish Society of Hospital Pharmacy position paper on biosimilar medicines

Ist Teil von

• Farmacia Hospitalaria, 2018-07, Vol.42 (4), p.180-183

Ort / Verlag

Spain: Grupo Aula Médica

Erscheinungsjahr

2018

Quelle

MEDLINE

Beschreibungen/Notizen

• 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.