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National experience with biologicals, including biosimilars Posted 03/03/2017

The European Commission (EC) held its second Multi-stakeholder Workshop on Biosimilar Medicinal Products in Brussels, Belgium on 20 June 2016 [1]. The aim of such workshop is to encourage timely access to biosimilars in Europe.

The workshop included a session on ‘Closing the Translational Gap: Sharing experiences at national level with biologicals, including biosimilars’. The session was designed to give an overview of developments regarding biosimilar competition, experiences with the use of biosimilars at national level and initiatives undertaken to build understanding and share best practice.

Moderator of the session, Professor Mondher Toumi from Aix Marseille University, France, noted that biosimilar policies across Europe remain extremely heterogeneous, suggesting that this would affect prices and, ultimately, market penetration.

Dr Vito Annese from Careggi Hospital Florence, Italy, presented the findings of the PROSIT-BIO study, to date one of the largest studies on switching to or first time use of biosimilar infliximab in over 500 patients with inflammatory bowel disease (IBD). Data from the study, where approximately 100 patients switched from infliximab, so far appear to demonstrate a comparable efficacy and safety when compared to the originator [2].

Mr Kevin Klein and Dr Pieter Stolk, representing Utrecht University, The Netherlands and Lygature/the Escher Project, presented a study about the traceability of biologicals after the implementation of the new pharmacovigilance legislation in The Netherlands. The results showed that brand names are not routinely recorded in clinical practice and batch numbers are poorly recorded. The findings suggest that the limited traceability of brand names and batch numbers in adverse drug reaction (ADR) reports for biologicals may be primarily caused by the shortcomings in the recording and tracing of information in clinical practice [3].

Dr Fraser Cummings, consultant gastroenterologist at the University Hospital of Southampton NHS Foundation Trust, UK, showcased switching data with infliximab from a study with patients with IBD. The study is a valuable example to incentivize all involved parties. The switch to the biosimilar allowed Dr Cummings to treat more patients, expand his team and still manage savings of GBP 60‒80,000 per month [4].

Dr Krisztina Gecse, gastroenterologist at the Department of Medicine, Semmelweis University in Budapest, Hungary, conducted a prospective, nationwide, multicentre, observational study to analyse the efficacy and safety of infliximab biosimilar CT-P13 in patients with Crohn’s disease and ulcerative colitis. It was concluded that real life experience with biosimilar infliximab CT-P13 suggests high response and remission rates similar to those reported earlier with the originator. 

Related articles
Revised Q&As on biosimilars for patients 

Closing the information gap for biosimilars

EC workshop on biosimilars aims to improve uptake 

1. European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs. Second multi-stakeholder workshop on biosimilar medicinal products; 20 June 2016; Brussels, Belgium.
2. Annese V, Gabbani T, Annese AL. Biosimilars in Italy: a gastroenterologist’s view. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(3):131-3. doi:10.5639/gabij.2016.0503.033
3. GaBI Online - Generics and Biosimilars Initiative. Pharmacovigilance for biologicals in The Netherlands [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 21]. Available from: www.gabionline.net/Biosimilars/Research/Pharmacovigilance-for-biologicals-in-The-Netherlands
4. GaBI Online - Generics and Biosimilars Initiative. Safe for IBD patients to switch to biosimilar infliximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 21]. Available from: www.gabionline.net/Biosimilars/Research/Safe-for-IBD-patients-to-switch-to-biosimilar-infliximab

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