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Spanish gastroenterologists update biosimilar position statement Posted 30/03/2018

The Spanish Society of Gastroenterology (Sociedad Española de Patología Digestiva,SEPD) has updated its position statement on the use of biosimilars for inflammatory bowel disease (IBD) [1]. The changes in the society’s position reflect the increasing body of evidence supporting the safety and efficacy of biosimilars.

The first monoclonal antibody biosimilar Inflectra/Remsima (infliximab; CT‑P13) gained European Commission approval in September 2013 [2]. Following this approval, the SEPD and the Spanish Society of Pharmacology (Sociedad Española de Farmacología) issued a joint position statement stating that the task force ‘considers that results obtained from studies in rheumatoid arthritis should not be extrapolated to IBD since the biological variability of these complex structures will not ensure a lack of noticeable changes in efficacy and safety’ [3].

However, since then, many studies in IBD have been published and have supported the biosimilarity of CT‑P13 with the reference product. Recently, the Norwegian NOR-SWITCH study [4] in immune-mediated diseases ‘did not find any differences in the maintenance of remission or adverse events in patients that switched from the reference product versus patients with the reference product’. Furthermore, the European Crohn’s and Colitis Organisation (ECCO) has also published a new position statement in which it supports switching from reference infliximab to biosimilar infliximab in IBD patients [5].

In light of this new evidence and advice from other societies, the SEPD has approved the following statements with respect to biosimilars:

1. A biosimilar is a drug that, using molecular biology techniques, is intended to provide an action equivalent to that of the product it attempts to copy and requires a complex process based on all the preclinical and clinical trials demanded by European Law.
3. A licence obtained for the management of a certain disease allows an extrapolation of results to a different disorder, if the European Medicine Agency considers it based on the results of trials mentioned previously.
4. The product label should clearly show the name of the biosimilar so that the drug a patient is taking may always be identified.
5. Based on the data published, the biosimilar CT‑P13 is safe and effective in IBD, both in naïve and switched patients.
6. The appropriate use of the biosimilar always requires an interaction of physicians and patients with the aim of favouring the right of the health of the patient by offering quality, effective and safe products.
8. This task force favours the development of biosimilar drugs and therefore, their approval by regulatory agencies.

The European Federation of Pharmaceutical Industries and Associations (EFPIA), European Biopharmaceutical Enterprises (EBE) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) have also issued joint position paper entitled ‘Considerations for physicians on switching decisions regarding biosimilars prescribers’ [6].

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References
1. Argüelles Arias F, Hinojosa Del Val J, Vera Mendoza I. Update of the SEPD position statement on the use of biosimilars for inflammatory bowel disease. Rev Esp Enferm Dig. 2018 Mar 12;110. doi: 10.17235/reed.2018.5456/2018. [Epub ahead of print]
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 30]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Extrapolation of biosimilar infliximab indications to inflammatory bowel disease [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 30]. Available from: www.gabionline.net/Biosimilars/Research/Extrapolation-of-biosimilar-infliximab-indications-to-inflammatory-bowel-disease
4. GaBI Online - Generics and Biosimilars Initiative. NOR-SWITCH study finds biosimilar infliximab not inferior to originator [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 30]. Available from: www.gabionline.net/Biosimilars/Research/NOR-SWITCH-study-finds-biosimilar-infliximab-not-inferior-to-originator
5. GaBI Online - Generics and Biosimilars Initiative. European IBD specialists support switching to biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 30]. Available from: www.gabionline.net/Biosimilars/General/European-IBD-specialists-support-switching-to-biosimilars
6. GaBI Online - Generics and Biosimilars Initiative. Pharma associations issue position paper on biosimilar switching [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 30]. Available from: www.gabionline.net/Biosimilars/General/Pharma-associations-issue-position-paper-on-biosimilar-switching

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