European Commission approves subcutaneous infliximab biosimilar for RA

The European Commission has approved the subcutaneous formulation of Celltrion’s infliximab biosimilar for adult patients with active rheumatoid arthritis who have had an inadequate response to a prior DMARD, as well as patients with severe, active and progressive disease not previously treated with DMARDs, according to a manufacturer press 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 subcutaneous formulation — 120 mg within prefilled syringes — is intended to provide a more consistent drug exposure between patients as well as more convenient administration.

“The approval of Remsima SC in Europe gives patients the opportunity to administer the treatment themselves as an injection, giving them more control over their own treatment,” Rene Westhovens, MD, PhD, global principal investigator and rheumatologist at the University Hospitals KU Leuven, in Belgium, said in the release. “Remsima SC has been shown to have a stable potency, and patients with RA on Remsima SC develop fewer anti-drug antibodies – which can improve the effectiveness of a treatment – compared with those on CT-P13 IV.”

The European Commission based its approval on study findings presented at ACR/ARP 2019, which examined efficacy, pharmacokinetics and safety, including immunogenicity, of CT-P13 SC during a one-year treatment period and following a switch from the IV formulation to the subcutaneous formulation among patients with RA.

According to study results, switching patients from the IV formulation to the subcutaneous formulation of CT-P13 treatment at week 30 was comparable to continuing CT-P13 SC up to week 54; safety results of CT-P13 SC showed similar profiles to the IV formulation up to week 64. In addition, CT-P13 SC achieved a sustained mean serum concentration and demonstrated a comparable efficacy profile to the IV formulation.

“The development of Remsima SC demonstrates that Celltrion is not just a biosimilar company, it is also an innovative company that strives for novel solutions such as the SC formulation of biosimilar infliximab,” Hyoung-Ki Kim, vice chairman at Celltrion, said in the release. “We develop cost-effective and patient-centered treatments to enable more patients to gain access to biologics that have proven efficacy and safety profiles. Celltrion expects to launch Remsima SC across Europe in the first quarter of 2020.”

According to the release, the company has also filed a supplemental variation to the marketing authorization for Remsima SC to extend the indication to include inflammatory bowel disease, with approval decision expected in mid-2020.

The European Commission has approved the subcutaneous formulation of Celltrion’s infliximab biosimilar for adult patients with active rheumatoid arthritis who have had an inadequate response to a prior DMARD, as well as patients with severe, active and progressive disease not previously treated with DMARDs, according to a manufacturer press 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 subcutaneous formulation — 120 mg within prefilled syringes — is intended to provide a more consistent drug exposure between patients as well as more convenient administration.

“The approval of Remsima SC in Europe gives patients the opportunity to administer the treatment themselves as an injection, giving them more control over their own treatment,” Rene Westhovens, MD, PhD, global principal investigator and rheumatologist at the University Hospitals KU Leuven, in Belgium, said in the release. “Remsima SC has been shown to have a stable potency, and patients with RA on Remsima SC develop fewer anti-drug antibodies – which can improve the effectiveness of a treatment – compared with those on CT-P13 IV.”

The European Commission based its approval on study findings presented at ACR/ARP 2019, which examined efficacy, pharmacokinetics and safety, including immunogenicity, of CT-P13 SC during a one-year treatment period and following a switch from the IV formulation to the subcutaneous formulation among patients with RA.

According to study results, switching patients from the IV formulation to the subcutaneous formulation of CT-P13 treatment at week 30 was comparable to continuing CT-P13 SC up to week 54; safety results of CT-P13 SC showed similar profiles to the IV formulation up to week 64. In addition, CT-P13 SC achieved a sustained mean serum concentration and demonstrated a comparable efficacy profile to the IV formulation.

“The development of Remsima SC demonstrates that Celltrion is not just a biosimilar company, it is also an innovative company that strives for novel solutions such as the SC formulation of biosimilar infliximab,” Hyoung-Ki Kim, vice chairman at Celltrion, said in the release. “We develop cost-effective and patient-centered treatments to enable more patients to gain access to biologics that have proven efficacy and safety profiles. Celltrion expects to launch Remsima SC across Europe in the first quarter of 2020.”

According to the release, the company has also filed a supplemental variation to the marketing authorization for Remsima SC to extend the indication to include inflammatory bowel disease, with approval decision expected in mid-2020.

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