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Pfizer and Celltrion Seek Biosimilar Interchangeability for Crohn’s Disease Drug



The Phase III clinical trial – conducted in partnership with Celltrion – found no statistical difference in response rates for patients taking Inflectra (infliximab CT-P13) or Remicade (infliximab).

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February 27, 2017 | by Sarah Hand, M.Sc.

Pfizer recently reported that its biosimilar version of Johnson and Johnson’s Remicade, showed similar efficacy compared to the reference biologic in patients with moderate-to-severe Crohn’s disease. The Phase III clinical trial – conducted in partnership with Celltrion – found no statistical difference in response rates for patients taking Inflectra (infliximab CT-P13) or Remicade (infliximab).

“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 Dr. Sam Azoulay, Senior Vice President, Chief Medical Officer, Pfizer Essential Health, Pfizer. “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.”

This study is also investigating the safety and efficacy of patients who switched from Remicade to Inflectra, or vice-versa. If those results are similarly positive, the study could support the approval of Inflectra as an interchangeable biosimilar to Remicade.

In January, the FDA released draft guidance on interchangeability requirements for biosimilars, which requires the copycat biologics to demonstrate the same clinical results as their branded counterparts for all indications. To date, none of the few approved biosimilars have met these requirements.

If Pfizer and Celltrion are able to show interchangeability for Inflectra, pharmacies would be able to dispense the less costly drug to patients with a prescription for Remicade. Pharmacists already practice drug substitution when a generic version of a branded pharmaceutical is available.

The randomized, double-blind, parallel-group trial enrolled 214 patients with Crohn’s disease. The primary endpoint was to show that the safety and efficacy of Inflectra was no different to that of Remicade, and this endpoint was met by the end of the sixth week of the 54-week study.

Patients treated with Inflectra saw a 71.4 percent response rate, compared to 75.2 percent for patients given Remicade. The treatment response was measured based on the number of patients who had a minimum 70-point reduction on the Crohn’s Disease Activity Index (CDAI-70).

Pfizer and Celltrion expect further study results to be available later this year. In 2016, Remicade sales hit $6.97 billion; if granted interchangeability, Inflectra has the potential to be a significant competitor in the Crohn’s market.

Keywords: Biosimilar, Biologic, FDA


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