On February 17, 12-month data from the Personalized Anti-TNF therapy in Crohn’s disease Study (PANTS) was presented at the 13th Congress of the European Crohn’s and Colitis Organization (ECCO).

The highly anticipated results did not disappoint biosimilar loyalists, and demonstrated that Celltrion ’s CT-P13 (infliximab biosimilar) is comparable to its reference, Johnson and Johnson’s Remicade (infliximab), as well as AbbVie ’s Humira (adalimumab). Given the dearth of head-to-head trial data for the same, such real-world evidence is expected to bolster the use of biosimilars and thus offer cost-effective treatment strategies for patients with Crohn’s disease (CD).

Study for potential Crohn’s disease treatment

Conducted in the UK, PANTS is a three-year prospective study that assessed 1,601 patients with active CD who had received no prior treatment with an anti-tumour necrosis factor (TNF) drugs. Of these, 751 patients received Remicade, 200 received the biosimilar, and 650 received Humira.

The rates of primary non-response were 21% in the Remicade group, 21% in the infliximab biosimilar group, and 26% in the Humira group at Weeks 12–14. At the end of the 12-month study period, the remission rates were 40%, 40%, and 34% for the Remicade, infliximab biosimilar, and Humira groups, respectively, while the immunogenicity rates were 26%, 28%, and 11%, for the respective treatment arms.

Many key opinion leaders (KOLs) interviewed by GlobalData have opined that biosimilars are as safe and effective as the branded biologics; however, they have emphasized the need for additional clinical data. Therefore, the findings from PANTS will further support the use of infliximab biosimilars over the originator brands.

GlobalData anticipates biosimilars will grow at a compound annual growth rate (CAGR) of 45.2%, from $32.6M in 2016 to $1.4B in 2026 across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) in the CD market.

Infliximab biosimilar use in the CD market

Considering the next steps for promoting biosimilar use in the CD market, real-world evidence supporting the switching of the originators to the biosimilars would be essential. According to KOLs, the current use of infliximab biosimilars is mostly restricted to infliximab-naïve patients; the PANTS study also focuses on this patient population.

The interviewed gastroenterologists have expressed reluctance in switching a patient who is stable on Remicade to the biosimilar infliximab, due to concerns of the psychological impact on the patient, a situation similar to the use of generics.

Therefore, future clinical trials, as well as real-world switching studies demonstrating the continued safety and efficacy of biosimilar use, would go a long way in entrenching these cost-effective agents firmly into the CD pharmaceutical armamentarium.