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Irish Evidence Shows Lag Between Approval, Acceptance of Biosimilar Infliximab


“A [3]-year time lag for the next biosimilar medicine, from market authorization to the patient switching process, should not occur," say the authors of a recent review.

Ireland is currently reworking its approach to using biosimilar medicines, given low uptake of these drugs to date as well as some reluctance on prescribers’ part to use biosimilars in a clinical setting. A newly published descriptive review sought describe how evidence was used by a large acute teaching hospital in Ireland to introduce biosimilar infliximab—CT-P13, sold in the European Union as Remsima and in the United States as Inflectra—for the treatment of inflammatory bowel disease (IBD).

After the biosimilar was approved by the European Medicines Agency (EMA) and licensed by the European Commission, the European Crohn’s and Colitis Organisation (ECCO) released a position statement saying that most biosimilars in patients with IBD should be tested in IBD specifically, not used on the basis of extrapolation from testing in other indications. ECCO also suggested that the decision to use a biosimilar should be made on a patient-by-patient basis.

Despite this statement, the chief pharmacist and consultant gastroenterologist in the Irish teaching hospital introduced the biosimilar for use by new patients in 2014.

“Both parties had been documenting the evidence trail since the licensing of this biosimilar in June 2013 and believed there was enough accumulated evidence from various sources to support their decision,” say the report’s authors, and the pharmacist and gastroenterologist conveyed the decision in an internal staff meeting via a presentation on the science behind this choice.

All physicians reportedly accepted the decision, agreed to prescribe the biosimilar for all new patients, and agreed to report any adverse events to relevant authorities. The authors say that, as patients were given reassurance on the safety and efficacy of the biosimilar, physicians did not face resistance to the prescribed agent.

After the hospital’s adoption of CT-P13, the British Society of Gastroenterology (BSG) updated its guidance to justify the introduction of the biosimilar, but cautioned against switching among products until safety data became available. In 2015, the National Institute for Health and Care Excellence (NICE) voiced support for prescribing the biosimilar, and Ireland’s Health Products Regulatory Authority released a guide to biosimilars for healthcare providers and patients.

In 2016, NICE and BSG updated their guidance to indicate that clinicians—in consultation with patients—should be the final authority on switching, and products should not automatically be substituted at the pharmacy level. BSG added that stable patients may be considered for switching (after consultation with the patient). Later the same year, the European Commission released its guidance on biosimilars, stating that these drugs are expected to be just as safe and effective as their references.

Following these changes, the chief pharmacist and consultant gastroenterologist of the hospital in question elected to switch all patients who were stable on the originator infliximab to the biosimilar. Again, all physicians agreed to the decision. Clinicians reported that they “found it more challenging to reassure patients of the switch at first,” but after educating patients and addressing their questions and concerns, “no opposition to switching arose.”

Approximately 1 month after the switch, the extrapolative subgroup analyses of patients with Crohn disease and ulcerative colitis within the NOR-SWITCH study showed similarity between patients treated with originator and biosimilar infliximab in terms of efficacy, safety, and immunogenicity. Despite the small sample size in this subgroup, ECCO updated its guidelines after these data were released, saying that switching patients was acceptable.

The report’s authors say that the decision to treat patients with the biosimilar was multifactorial and was supported by “a robust and extensive evidence-based trail that ultimately convinced prescribing physicians,” although the decision preceded any similar efforts in other hospitals and predated the NOR-SWITCH data.

However, despite the fact that this hospital moved more quickly than any other in the nation, the decision to switch patients “could have been regarded as over cautious, delayed and conservative given that EMA had already licensed the biosimilar medicine [3] years earlier and thus, one wonders why prescribers had not switched patients sooner,” write the authors, who add that “a [3]-year time lag for the next biosimilar medicine, from market authorization to the patient switching process, should not occur.”


O’Brien, GL, Carrol D, Mulcahy M, Walshe V, Courtney G, Byrne S. Biosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: a story behind the evidence [published online February 27, 2018]. GaBI J. gabi-journal.net/biosimilar-infliximab-introduction-into-the-gastroenterology-care-pathway-in-a-large-acute-irish-teaching-hospital-a-story-behind-the-evidence.html.

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