Pfizer and Celltrion Healthcare have unveiled new data showing that switching patients with Crohn’s disease from Remicade to biosimilar Inflectra showed comparable efficacy, safety and tolerability over a 24-week period.
According to the companies, the full 54-week results of the randomised controlled trial comparing the drugs in biologic-naïve patients with active Crohn’s disease support the long-term effectiveness of treatment with Inflectra (infliximab CT-P13).
“These data support previous findings which demonstrate the importance of CT-P13 as a treatment option for patients with Crohn’s disease, providing healthcare professionals further confidence when stable patients switch to CT-P13 from Remicade,” said Stephen B Hanauer, Professor of Medicine-Gastroenterology and Hepatology, Feinberg School of Medicine, Northwestern University, US.
Earlier this year the firms presented data from the 220-patient clinical trial showing that, at six weeks in, the biosimilar was comparable to its reference drug.
The study 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. At six weeks the response rates - 71.4 percent for Inflectra and 75.2 percent for Remicade - were not statistically significantly different.
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.