Celltrion showed confidence in a subcutaneous version of Remsima, a biosimilar referencing Johnson & Johnson’s Remicade, saying it will meet the needs of a wider range of patients when it hits markets next year.

“We will seek marketing approval for Remsima SC in October after completing clinical trials in September,” Celltrion Chairman Seo Jung-jin said in a telephone interaction with 27,000 shareholders during a general shareholders meeting in Songdo, Incheon, on March 23.

Remsima is approved in 90 countries including the US and Europe. The latest under-the-skin injection formula is designed to offer a more convenient self-administered pen type option to patients.
Currently, the original drug and Celltrion’s biosimilar are only available as intramuscular injections administered directly into the muscle.

“Physicians in the US and Europe told us that it makes sense to adopt Remsima SC when it launches,” the chairman said.
Celltrion expects the new version to encompass patients with inflammatory bowel disease who are being treated with other anti–tumor necrosis factor alpha, or TNF-α, therapies including Humira, Enbrel as well as the original Remicade. 

Patients with inflammatory bowel disease account for some 60 percent of the TNF-α market, and physicians are willing to prescribe the subcutaneous formulation for patients with mild bowel disease while those with severe conditions are required to be administered intravenous injections.

By Park Han-na (hnpark@heraldcorp.com)