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Pfizer’s Remicade biosimilar receives Crohn's trial boost

Inflectra shown to be similar to originator in data presented at ECCO in Barcelona

Pfizer 

Pfizer's biosimilar version of Remicade (infliximab) has been shown to have similar safety and efficacy to its originator in Crohn's disease.

The trial of Inflectra (infliximab CT-P13) provides the first biosimilar clinical data in Crohn's and will give Pfizer further ammunition in its battle against Janssen's blockbuster.

Presented at the European Crohn's and Colitis Organisation (ECCO) Congress on Friday, the randomised clinical trial involved 214 patients with moderate-to-severe Crohn's disease and will eventually run for 54 weeks.

In it Inflectra met its primary end point by demonstrating at six-weeks it was similar to Remicade. The trial evaluated the number of patients whose Crohn's Disease Activity Index score fell by 70 points or more and, at 71.4% for Inflectra and 75.2% for Remicade, Pfizer said the results were not statistically significantly different.

Six-week data also showed Inflectra had a similar safety and tolerability profile as Remicade, and no new safety signals were identified.  

Sam Azoulay, chief medical officer at Pfizer Essential Health, Pfizer, said: “[The] presentation of randomised control trial data in patients with Crohn's disease further supports the existing clinical profile of CT-P13 in inflammatory bowel disease. 

“In addition to existing data from the registration studies, real-world experience and the NOR-SWITCH trial, this data adds to the body of evidence supporting use of CT-P13 across its approved indications of use.”

Further results on Inflectra's longer-term safety and efficacy from the ongoing Crohn's disease study are expected later this year, as should be information on its treatment response and safety in patients who are switched from Remicade to the biosimilar.

That issue has already been studied to some extent in the NOR-SWITCH trial of Remicade and biosimilar infliximab, work that found no safety issues and similar efficacy.

Inflectra was originally developed by South Korea-based Celltrion and licensed in 2009 by Hospira, which Pfizer then acquired for $15bn in 2015.

After receiving European approval in 2013, the biosimilar's US approval took a year longer than expected, with the FDA not giving it the greenlight until 2016. When it came the US approval covered six indications, including rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis and Crohn's disease.

Article by
Dominic Tyer

20th February 2017

From: Research

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