Hungarian experience with the use of biosimilar infliximab in IBD

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Hungarian experience with the use of biosimilar infliximab in IBD

INICIO/Informes | Posted 31/03/2017 0 Post your comment

In a study of real life experience with biosimilar infliximab CT‑P13 the results suggest high response and remission rates similar to those previously reported with the originator biological [1].

Treatment with biologicals is centralized to 15 centres in Hungary. Hospira’s infliximab biosimilar Inflectra (CT‑P13) entered the Hungarian market in May 2014. The Hungarian National Health Fund only reimburses Inflectra for new induction treatment in inflammatory bowel disease (IBD). New induction is defined as no infliximab treatment in the previous 12 months. Switching is not allowed.

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 (CD) and ulcerative colitis (UC).

Endpoints in the trial included clinical remission in luminal CD (CDAI < 150), clinical remission in fistulizing CD (no fistula drainage), clinical remission in UC (pMayo < 3), clinical response in luminal CD (CDAI-70), clinical response in fistulizing CD (≥ 50% reduction in the number of draining fistulas), clinical response in UC (pMayo decrease > 3).

The results obtained with Inflectra suggest high response and remission rates similar to those previously reported with the originator biological, Johnson & Johnson and Merck’s Remicade. The adverse event (AE) profile and rates for Inflectra were also comparable with those of the originator. Induction treatment with the biosimilar was, however, less effective in patients previously exposed to the originator and AEs were more common in patients with previous exposure to the originator.

EC workshop on biosimilars aims to improve uptake

Reference
1. Gecse K. Hungarian experience with the use of biosimilar infliximab in IBD. European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs. Second multi-stakeholder workshop on biosimilar medicinal products; 20 June 2016; Brussels, Belgium.

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