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Biosimilars to replace older biologicals for IBD Posted 07/06/2019

Biosimilars will gradually replace older biological drugs for IBD, however, issues – such as the safety of multiple switches – remain, says a recent assessment published in Digestive Diseases and Sciences [1].

Inflammatory bowel disease (IBD) comprises a range of inflammatory conditions affecting the colon and small intestine, namely including Crohn’s disease and ulcerative colitis. It is a global public health challenge, with 1.5 million people in North America and 2 million people in Europe suffering from the disease, which can seriously affect quality of life.

Biological drugs (particularly those targeting tumour necrosis factor alpha [TNF-α] signalling) have offered effective treatment for IBD, helping to improve symptoms and heal mucosal damage. However, cost issues have motivated the development of several biosimilar treatments in recent years [2].

Biosimilars (therapeutic antibodies closely resembling the originator product) increase competition in the pharmaceutical market and reduce the economic burden of therapy for IBD, increasing access for patients and reducing overall healthcare costs.

Infliximab is a TNF-α inhibitor and commonly used treatment for IBD. Marketed as Remicade by Janssen Biotech, Inc in the US, it can cost as much as US$19,000 per month.

CT-P13 was the first infliximab biosimilar approved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), where it has been marketed in the EU since 2013 and 2016, respectively.

Despite the clear cost savings, the use of biosimilars has been debated due to the regulatory process, as use of biosimilars can be extended to all indications of the reference product without the need for individual clinical trials.

There have also been concerns about the ‘nocebo’ effect, whereby a patient may experience adverse effects when switching to a new drug. A trial of 482 IBD patients, for example, showed a trend towards disease worsening when switching to CT-P13, although this trend was not significant.

This review [1] discusses a more recent study in a cohort of over 100 Crohn’s disease patients in Scotland, also switching to CT-P13. This study found no significant difference to disease or inflammatory markers at 6 and 12 months after the switch, and no infusion reactions or unexpected safety concerns were noted. The average cost saving in this study was 50% compared with the originator.

The review says this study demonstrates there is patient confidence in switching, provided there is full and appropriate communication, and supports the idea that resources saved by using biosimilars can be reinvested into the same patients.

However, there are still issues regarding the use of biosimilars in IBD, including the safety of multiple switches (between reference product and biosimilar, or between multiple biosimilars).

The manuscript closes with a number of take-home messages, summarized here:
• Biosimilars will gradually replace older biological treatments for IBD
• The use of biosimilars increases patient access to the most effective IBD treatments
• Education is key to establish patient confidence when switching to a biosimilar
• The safety and efficacy of CT-P13 has largely been demonstrated
• The issue of multiple switching requires further investigation

Editor’s comment
Readers interested to learn more about biosimilars for inflammatory bowel disease are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:

Biosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: a story behind the evidence

First biosimilar of infliximab approved in Brazil: response from the Brazilian IBD society

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

Related articles
Switching to biosimilar infliximab in IBD patients

Biosimilar infliximab safe and effective in IBD

Post-marketing experience with IBD biosimilars

References
1. Annese V. Biosimilars in IBD: similarity breeds contented patients. Dig Dis Sci. 2019;64(6):1399-400.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars in the treatment of inflammatory bowel disease [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 7]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilars-in-the-treatment-of-inflammatory-bowel-disease

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