Celltrion received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for the subcutaneous formulation of its infliximab biosimilar intended to treat rheumatoid arthritis, according to a manufacturer release.
The biosimilar, CP-P13 SC, is a subcutaneous version of Remsima (infliximab-dyyb, Celltrion), which was originally approved for use in the European Union in 2013. The new formulation — 120 mg within prefilled syringes — is intended to provide a more consistent drug exposure between patients as well as more convenient administration.
“Today’s positive CHMP opinion brings us one step closer to providing a personalized treatment approach for people living with rheumatoid arthritis. This marks an important milestone for our business providing people with a new route of administration, and a novel formulation of infliximab,” Hyoung-Ki Kim, vice chairman at Celltrion, said in a press release. “If approved, we will begin a new era in the biotherapeutic class, as CT-P13 SC would be the world’s first subcutaneous version of infliximab, expanding treatment options for physicians and their patients.”
The committee based its decision on data from a combined phase 1 and phase 3 study, presented by Yoo and colleagues at EULAR 2019, which examined efficacy, pharmacokinetics and safety differences between CT-P13 SC and the IV formulation among patients (n = 50) with active RA.
Celltrion received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for the subcutaneous formulation of its infliximab biosimilar intended to treat RA.
According to initial study results, CT-P13 SC demonstrated comparable efficacy to CT-P13 IV up to week 54 with comparable DAS28 (CRP)/DAS28 (ESR) and ACR20 scores established for both routes of administration. The safety profile of CT-P13 SC was also similar to CT-P13 IV.
In a follow-up randomized controlled trial, CT-P13 SC was found to be noninferior for efficacy to CT-P13 IV among patients with RA (n = 362) over 30 weeks, demonstrating similar DAS28 and ACR20, ACR50, ACR70 scores and EULAR-CRP response. Additionally, the safety profile of CT-P13 SC was similar to CT-P13 IV up to week 30.
“This announcement is very encouraging as CT-P13 SC has demonstrated a comparable safety and efficacy profile to the well-established intravenous version of infliximab,” Rene Westhovens, MD, PhD, global principal investigator and rheumatologist at the University Hospitals KU Leuven, in Belgium, said in the release.
He added, “This new SC formulation of infliximab could give patients the opportunity to administer the treatment themselves as an injection, giving them more control over their own treatment. Having two 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.”
If approved by the European Commission, the treatment will be granted centralized marketing authorization valid in the 28 countries of the European Union. Countries that are not members of the EU but part of the European Economic Area — Norway, Iceland and Liechtenstein — are expected to make corresponding decisions based on the European Commission’s recommendation.
According to the release, a phase 3 study of CT-P13 SC for patients with inflammatory bowel disease is currently underway, and the company “hope[s] to seek expanded indications following the results of this trial.”