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Spanish pharmacists publish biosimilar position statement Posted 22/02/2019

The Spanish Society of Hospital Pharmacy (Sociedad Española de Farmacia Hospitalaria, SEFH) has published a position statement on the use of biosimilars [1]. The statement expresses the position of the society on the strategies to be followed concerning the processes of selecting, evaluating and implementing these types of medicines in the healthcare setting.

Miguel Ángel Calleja, President of SEFH, gave a presentation on the position paper at the fourth European Commission Stakeholder Conference on Biosimilar Medicines, which was held on 14 September 2018 in Brussels, Belgium [2].

During his presentation, Mr Calleja pointed to the following statements about biosimilars that are made by SEFH in the position paper:
1. A strong regulatory framework is available.
2. Biosimilars are safe.
3. Extrapolation of indications where safety and efficacy have been demonstrated for another indication between the reference drug and the biosimilar.
4. Interchangeability between the reference medicine and the biosimilar is increasingly based on better evidence.
5. The Hospital Pharmacy and Therapeutics Committee and the Regional Committees play a key role in the evaluation and inclusion of biosimilars in hospitals. They establish the criteria of use, therapeutic exchange and monitoring.
6. The traceability of biosimilars must be guaranteed.
7. Information on biosimilar medicines should be offered.
8. Biosimilars support the sustainability of the health system.
9. Hospital pharmacists play a key role in the pharmacotherapeutic management of biosimilars.

Mr Calleja also compared how the SEFH position statement compares to the European Association of Hospital Pharmacists (EAHP) position statement on biosimilars.

The EAHP adopted its position paper on biosimilars in June 2018 [3]. The two position papers have common topics including the following:
• The EAHP has confidence in the European Medicines Agency’s (EMA) regulatory pathway for biological reference products and biosimilars, including extrapolation of indications.
• The EAHP supports the interchangeability, switching and substitution of biosimilars.
• The EAHP, as for all other medicines, recommends informed patient involvement and shared decision-making.
• The EAHP advocates the role of hospital pharmacists regarding the uptake of biosimilars in healthcare in terms of selection, procurement, logistics, information, education and collecting real-life experience.

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References
1. Martínez-López de Castro N, Matilla-Fernández MB, Fraga-Fuentes MD, et al. Spanish Society of Hospital Pharmacy position paper on biosimilar medicines. Farm Hosp. 2018;42(4):180-3.
2. Calleja MA. Spanish Society of Hospital Pharmacy Position Paper on Biosimilar Medicines. 4th European Commission Stakeholder Conference on Biosimilar Medicines; 14 September 2018; Brussels, Belgium.
3. European Association of Hospital Pharmacy. EAHP General Assembly welcomes new President and adopts position on procurement [homepage on the Internet]. [cited 2019 Feb 22]. Available from: www.eahp.eu/press-room/eahp-general-assembly-welcomes-new-president-and-adopts-position-procurement

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