Crohn's Disease Biosimilar Shows Similarity to Reference Product

Pfizer and Cellitron Healthcare recently presented safety and efficacy data for the biosimilar Inflectra (infliximab CT-P13) at the 12^th Congress of European Crohn’s and Colitis Organization.

According to results from a phase 3 clinical trial, the biosimilar Inflectra showed similar safety and efficacy to its reference product, Remicade (infliximab), in patients with moderate-to-severe Crohn’s disease.

Included in the study were 214 patients with Crohn’s disease who were randomized to receive Inflectra or Remicade, and potentially switch treatments during the study. The primary endpoint of the clinical trial was analyzed at 6 weeks to determine similarity between the 2 drugs, and to assess Crohn’s Disease Activity Index (CDAI)-70 response rates.

After week 30, patients treated with Remicade were randomized to continue with treatment or switch to Inflectra, and patients treated with Inflectra were randomized to either continue with treatment or switch to Remicade.

The investigators reported that Inflectra met the criterion for non-inferiority to Remicade at 6 weeks. The response rates were 71.4% for Inflectra and 75.2% for Remicade, which were not statistically significant, according to the press release.

By assessing clinical remission and CDAI-100 response rates, the researchers found that both treatments showed similar efficacy. Data analyzed at 6 weeks also indicated that the drugs had a similar safety and tolerability profile.

Patients experiencing an adverse events, serious adverse events, or adverse events of special interest were similar between both groups, with no new safety issues observed.

Additional results regarding long-term safety and efficacy data from the ongoing study are expected later this year, according to Pfizer. The researchers are also analyzing treatment response and safety profile in patients who switched treatment from Remicade to Inflectra, and from Inflectra to Remicade.

Inflectra was approved in April 2016 in the United States for numerous autoimmune diseases, including Crohn’s disease, making it the second biosimilar to receive approval.

The approval was based on evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and efficacy data to prove that Inflectra is biosimilar to Remicade.

The drug was launched in November 2016, and costs 15% less than the reference product. Pfizer previously announced that the wholesale acquisition cost for Inflectra would be $946 per vial, compared with $1113 per vial for Remicade.

“Today’s presentation of randomized control trial data in patients with Crohn’s disease further supports the existing clinical profile of CT-P13 in inflammatory bowel disease,” said Sam Azoulay, MD, senior vice president, Chief Medical Officer, Pfizer Essential Health. “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."