Pfizer and Celltrion have unveiled Phase III study data comparable safety and efficacy between biosmilar Inflectra and reference drug Remicade in patients with moderate-to-severe Crohn's disease (CD).
The randomized 54 week clinical trial in 214 patients met its primary end point in showing that, at six weeks, Inflectra (infliximab CT-P13) was similar to Remicade (infliximab) in the treatment of CD thereby meeting the criterion for non-inferiority.
The trial evaluated the number of patients experiencing a fall of 70 points or greater in the Crohn's Disease Activity Index (CDAI-70), a well-established assessment of treatment response in CD.
The response rates, 71.4 percent for Inflectra and 75.2 percent for Remicade, were not statistically significantly different, the firm's noted.
Additional disease activity measures used in the trial, clinical remission and CDAI-100 response rates, also demonstrated similar and consistent efficacy between the two treatments, while six-week data also showed similar safety and tolerability profiles.
"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," noted Sam Azoulay, chief medical officer, Pfizer Essential Health, Pfizer.
Further data on the longer-term safety and efficacy of Inflectra from this ongoing 54-week study in CD are expected later this year.
Pfizer holds exclusive commercialisation rights to Celltrion's Inflectra in the US, where it was approved in April last year across CD, ulcerative colitis, rheumatoid arthritis, active ankylosing spondylitis, active psoriatic arthritis and chronic severe plaque psoriasis indications.
In the EU Celltrion's biosimliar version of Remicade was launched in 2015, where it is marketed by several partners including Hospira UK and Napp Pharmaceuticals.