During its September 2019 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending a change to Celltrion’s marketing authorization for its biosimilar infliximab, CT-P13, sold in Europe as Remsima.
During its September 2019 meeting, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending a change to Celltrion’s marketing authorization for its biosimilar infliximab, CT-P13, sold in Europe as Remsima.
The CHMP recommended approval of Celltrion’s 120-mg solution of the biosimilar infliximab for subcutaneous injection, using prefilled pens or syringes, for the treatment of rheumatoid arthritis (RA). The next step for the biosimilar will be to await the European Commission’s final decision on whether to grant a change to the marketing authorization.
“Today’s positive CHMP opinion brings us one step closer to providing a personalized treatment approach for people living with [RA]. This marks an important milestone for our business providing people with a new route of administration, and a novel formulation of infliximab,” said Hyoung-Ki Kim, vice chairman of Celltrion Healthcare. “If approved, we will begin a new era in the biotherapeutic class, as CT-P13 [subcutaneous] would be the world’s first subcutaneous version of infliximab, expanding treatment options for physicians and their patients.”
Global principal investigator Rene Westhovens, MD, PhD, rheumatologist at the University Hospitals KU Leuven, Belgium, added that the subcutaneous biosimilar could give patients the chance to administer their infliximab therapy at home, giving them more control over their own treatment than has previously been possible with intravenously administered infliximab, which generally requires 2 hours to administer in the hospital setting. “Having  formulations of CT-P13 could also benefit patients by offering a more personalized treatment option whilst also reducing the time spent in hospital having intravenous treatment alone,” said Westhovens.
The positive CHMP opinion was based on data from a combined phase 1 and phase 3 study of the new formulation versus the intravenous version in patients with active RA.1 In the study, 50 patients with RA were enrolled and were treated with intravenous CT-P13 at weeks 0 and 2. They were then randomized to continue with the intravenous therapy or to transition to subcutaneous administration at week 6, and were followed to week 54. Efficacy results for the subcutaneous administration cohort were comparable to those of the intravenous administration cohort up to week 54, and safety profiles were also generally comparable.
In part 2 of the study, which enrolled 362 patients with RA, patients received intravenous CT-P13 at weeks 0 and 2, and were then randomized 1:1 to receive either intravenous or subcutaneous therapy thereafter. The mean change in disease activity score in a count of 28 joints with C-reactive protein from baseline to week 22 was similar between arms, and the lower limit of the 2-sided confidence interval (0.03) was greater than the prespecified noninferiority margin (—0.6), establishing noninferiority of the subcutaneous biosimilar to the intravenous version. Safety profiles were once again comparable.
In the US context, where CT-P13 is sold as Inflectra, Celltrion has also begun recruiting patients for a phase 3 clinical trial of the subcutaneous biosimilar with an eye toward FDA approval; in August of this year, the drug maker began to recruit patients with inflammatory bowel disease in Ohio for the study. Celltrion indicated that the FDA has exempted the company from having to conduct phase 1 or phase 2 clinical studies, given the amount of clinical data that the company has already generated in support of its submission of the product to the EMA.
1. Yoo D, Jaworski J, Matyska-Piekarska E, et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 1-year results from a part 1 of phase I/III randomized controlled trial in patients with active rheumatoid arthritis. Presented at: The European League Against Rheumatism European Congress of Rheumatology 2019, June 12-15, 2019; Madrid, Spain. Abstract FRI0129.
2. Westhovens R, Wiland P, Zawadzki M, et al. A novel formulation of CT-P13 for subcutaneous administration: 30 week results from a part 2 of phase I/III randomized controlled trial in patients with rheumatoid arthritis. Presented at: The European League Against Rheumatism European Congress of Rheumatology 2019, June 12-15, 2019; Madrid, Spain. Abstract SAT0170.