Why Remicade biosimilar sales will grow in the U.S.

Two new biosimilar announcements are expected to increase the uptake of the biosimilar infliximab to Johnson & Johnson’s Remicade for rheumatoid arthritis, Crohn’s disease, and other inflammatory conditions.

Pfizer said it will begin shipping its biosimilar version of Remicade (Inflectra, infliximab-dyyb) in late November at a 15% discount to the current wholesale acquisition cost of Remicade.

In addition, new data presented at the 2016 United European Gastroenterology (UEG) Week in Vienna, Austria in mid-October showed that a switch to biosimilar infliximab (CT-P13, manufactured by Celltrion) is not inferior to continued treatment with Remicade and that patients can be safely switched.

Physicians and consultants have expressed concerns about switching patients from branded drugs to biosimilars, especially since FDA has not said that biosimilars are exactly the same as their branded counterparts and can be used interchangeably, as is the case with generic drugs.

“Right now, FDA is just saying that the biosimilar for Remicade, for example, is ‘highly similar’. We are all waiting for some guidance from FDA that Drug A is completely substitutable for Drug B and vice versa,” said Robert Adamson, PharmD, Chief Pharmacy Officer, Corporate Pharmacy, for Barnabas Health in West Orange, N.J., which operates numerous hospitals and clinics, earlier this year.

The new clinical study, sponsored by the Norwegian government, involved nearly 500 patients at 40 sites across Norway who had stable on infliximab treatment for at least six months. The patients had chronic inflammatory diseases, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, or chronic plaque psoriasis.

In the 50% of patients switched to the biosimilar infliximab (CT-P13), the efficacy and safety were comparable to those who remained on Remicade. Plus, remission rates in Crohn’s disease and ulcerative colitis show were similar with CT-P13 and Remicade

In addition, the time to study drug discontinuation was almost identical between the two groups.

“The data show that safety and efficacy are maintained post-switch and should give confidence to physicians looking to move their patients onto biosimilar infliximab for non-medical reasons such as cost. I am hopeful that switching will lead to financial savings that can in turn enable more patients to receive this life-changing medicine,” said Jørgen Jahnsen, Professor of gastroenterology at the University of Oslo, Norway, and co-author of the NOR-SWITCH study.

A number of real-world studies that support the safety and efficacy of CT-P13 were also presented at UEG Week, including a study of a cohort of anti-TNF-naïve patients with inflammatory bowel disease. Researchers found that both efficacy and safety of CT-P13 were comparable to that observed previously with Remicade.

Notably, new data on real-world cost savings associated with the use of CT-P13 were also presented at UEG Week. When researchers looked at the savings of CT-P13 in Germany, France, Italy, Spain, and U.K., total 2015 cost savings ranged from €1.35 million in Germany to €5.97 million in Spain.

“The Spanish findings suggest that use of biosimilar infliximab (CT-P13) could allow up to 1,085 extra patients per year to access biologic therapy,” Celltrion said in a statement.