Pfizer’s Remicade biosimilar displays similar efficacy

Pfizer and Celltrion have announced new data for their Remicade biosimilar, Inflectra, that shows that the drug is comparable in safety and efficacy, in a recent Phase 3 trial treating Crohn’s disease. Remicade was worth sales of $5.76 billion to Johnson & Johnson in 2015.

The trial involved 214 patients and will run the course of 54 weeks to treat moderate-to-severe Crohn’s disease. The primary endpoints were reached after six weeks, as it was revealed that Inflectra managed to reduce Crohn’s Disease Activity Index  by 70 points or greater. Response rates were 71.4% in patients treated by Inflectra and 75.2% by Remicade. In addition

"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. 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," said Sam Azoulay, M.D., Senior Vice President, Chief Medical Officer, Pfizer Essential Health.

Pfizer owns the commercialisation rights to Inflectra in the US and has already received approval by the FDA in April 2016 for the treatment of multiple indications.

Inflectra sales are expected to eat into the profits of Remicade, but J&J will be hoping that the process will be a slow one – as the decision to prescribe is a decision made by physicians on a case-by-case basis.

Ben Hargreaves