Subcutaneous Formulation of Celltrion's Biosimilar Infliximab Authorized by European Commission

Celltrion Healthcare announced that the European Commission has authorized Remsima SC, a subcutaneously administered formulation of its biosimilar infliximab, CT-P13, for the treatment of rheumatoid arthritis (RA). The product is the first subcutaneous infliximab option to be approved in any regulatory territory.

The drug is authorized to treat RA in patients who are also taking methotrexate, those who have had an inadequate response to conventional disease-modifying antirheumatic drugs, and treatment-naïve patients.

Authorization was based on data that included those from a randomized phase 1 and phase 3 study among 348 patients with RA that showed the effectiveness and tolerability of the subcutaneous formulation at 1 year. The data also showed that patients can be safely switched to the subcutaneous formulation of CT-P13 from the intravenous formulation.¹

“The development of Remsima SC demonstrates that Celltrion Healthcare 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,” said Hyoung-Ki Kim, vice chairman at Celltrion Healthcare, in a statement announcing the authorization. “We develop cost-effective and patient-centered treatments to enable more patients to gain access to biologics that have proven efficacy and safety profiles.”

He added that Celltrion Healthcare has expanded its business operations in European markets ahead of an expected first quarter 2020 launch for the product. Speaking to The Center for Biosimilars^® earlier this month, Sang Joon Lee, PhD, senior executive vice president of Celltrion, said that although a price has not yet been set for the drug, it could help reduce costs related to infliximab therapy.

The drug maker has also applied for patents on subcutaneous infliximab in approximately 100 countries worldwide, including the United States, and says that the patents will protect the drug until 2038.

In addition to its indication in RA, the subcutaneous formulation has also been studied in inflammatory bowel disease (IBD), for which Celltrion is also seeking an indication from the European Medicines Agency. In a phase 1 pivotal study, the subcutaneous formulation and the intravenous formulation of CT-P13 were comparable in terms of clinical remission rates for patients with IBD at week 30 of treatment.²

A European decision on the drug in IBD is expected, says the company, by mid-2020. The drug maker is also enrolling a phase 3 study in the United States in patients with IBD to support an application to the FDA. In the US context, Celltrion has indicated, the subcutaneous product will be treated as a new product, rather than submitted under the biosimilar approval pathway.

References

1. Westhovens R, Wiland P, Zawadzki M, et al. Efficacy and safety of a novel subcutaneous formulation of CT-P13 over the 1-year treatment period and after switching from intravenous CT-P13 in patients with active rheumatoid arthritis: results from part 2 of phase I/III randomized controlled trial. Presented at: The American College of Rheumatology Annual Meeting; November 8-13, 2019; Atlanta, GA. Abstract 548.

2. Schreiber S, Leszczyszyn J, Dudkowiak R, et al. Noninferiority of novel subcutaneous infliximab (CT-P13) to intravenous infliximab (CT-P13) in patients with active Crohn’s disease and ulcerative colitis: week 30 results from a multicenter, randomized controlled pivotal trial. Presented at: United European Gastroenterology Week 2019; October 29-23, 2019; Barcelona, Spain.