Eye on Pharma: Celltrion and Pfizer Make Strides With Infliximab Biosimilar

In terms of both clinical data and sales, drug makers Celltrion and Pfizer have seen recent gains for their infliximab biosimilar, CT-P13 (Inflectra, Remsima).

At the 25th United European Gastroenterology Week in Barcelona

, Spain, drug maker Celltrion presented

data

from a phase 1, open-label study of a subcutaneous form of CT-P13 in healthy volunteers. The study, designed to evaluate the safety and pharmacokinetics of the infliximab biosimilar, found that subcutaneous administration of the drug was feasible in terms of bioavailability and safety, and the researchers suggested that a subcutaneous administration could present a more convenient and accessible option for patients receiving infliximab.

In addition to these results, Pfizer presented data from a 54-week, phase 3

study

that supported the long-term effectiveness of CT-P13 in patients with Crohn’s disease, and that supported switching from the reference product to the biosimilar.

A poster

presented at the same meeting reported on a biosimilar switching project carried out in the Rheumatology and Gastroenterology departments in the Princess Alexandra Hospital in the United Kingdom. Patients who had been receiving reference infliximab for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and irritable bowel disease were switched to biosimilar CT-P13. Patients were seen at 6 to 8 weeks post-switch to review their response to the biosimilar. The poster’s authors report that 13 patients responded well to the biosimilar, while 2 patients had to switch back to the originator biologic due to a loss of disease control. The main impact of the switch, the authors state, is the financial benefit and cost savings produced by switching.

CT-P13 also demonstrated gains in terms of third-quarter sales. Celltrion and Pfizer’s biosimilar was responsible for $112 million in worldwide sales over the quarter, with $34 million of those sales in the United States,

according

to Pfizer’s quarterly report. Meanwhile, Johnson and Johnson, makers of the reference infliximab (Remicade),

reported

slowing sales of its innovator drug; Remicade experienced a 1.3% drop in US sales, and an 8.2% drop in worldwide sales. The reference infliximab still commanded $1.6 billion of the global infliximab market, however.

While CT-P13's sales may not yet have achieved blockbuster status, performance of the drug in the United States is reason for optimism, according to some analysts. While US biosimilar uptake is typically slower than EU uptake, “Remsima sales went up [47.8%] in the [United States] this quarter, compared to the previous quarter. In Europe, it rose [42.2%] year-on-year. From 2018, it will see strong growth in earnest,” Shin Jae-hoon, analyst at EBEST Investment and Securities,

told

Korea Biomedical Review.