Celltrion to seek Europe approval for Remsima SC by year’s end

By Sohn Ji-young
  • Published : Aug 29, 2018 - 14:22
  • Updated : Aug 29, 2018 - 14:22

South Korean biopharma company Celltrion said Wednesday that it has concluded all clinical trials for its subcutaneous (SC) version of Remsima, and is scheduled to seek approval for the drug from European drug regulators by the year’s end.

Celltrion said it had concluded phase 3 clinical trials for Remsima SC and is now preparing to submit the drug for approval to the European Medicines Agency in the latter half of the year.

Celltrion employees are seen in an R&D lab at the company's headquarters in Songdo, Incheon (Celltrion)

After launching Remsima, a biosimilar referencing Remicade (infliximab), Celltrion has been working on a second-generation product: a subcutaneous version of the biosimilar that can be self-injected into the fatty tissue under the skin.

By freeing patients from hospital visits, Remsima SC would offer more convenience than both the original drug and Remsima, both of which are designed to be administered via intravascular injections, Celltrion said.

According to the Korean drugmaker, Remsima SC will target patients already being treated with infliximab, as well as patients using SC versions of other TNF-alpha inhibitor drugs including Humira and Enbrel.

Looking ahead, Celltrion predicts Remsima SC will take away around 30 trillion won ($27.07 billion) of the global TNF-alpha inhibitor drug market, and become another blockbuster drug in Europe next to Remsima.

By Sohn Ji-young (