Spanish pharmacists publish biosimilar position statement

Home/Reports | Posted 22/02/2019 post-comment0 Post your comment

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.

24 AA011041

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.

Related article
Changing attitudes for biosimilars in gastroenterology

Spanish gastroenterologists update biosimilar position statement

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:

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010