Celltrion seeks Europe drug regulator’s approval of Remsima SC

South Korean biopharmaceutical company Celltrion said Monday that the European Medicines Agency has accepted for review its Remsima SC -- a subcutaneous version of Remsima, a Celltrion-developed biosimilar referencing Johnson & Johnson’s autoimmune disease treatment Remicade.

Celltrion expects to receive an opinion from the EMA’s new drug approval committee on approving Remsima SC by the second half of 2019 at the earliest.

After launching Remsima, a biosimilar copy of 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. 

It differs from intravascular injections of Remsima and Remicade that require patients to visit hospitals for an injection. By freeing patients from hospital visits, Remsima SC offers more convenience than both the original drug and Remsima, 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.

“Diversifying our product lineup with Remsima, which has already taken up 54 percent of the intravascular infliximab market, we hope to pull up the drug’s shares to become a blockbuster drug in the global TNF-alpha inhibitor treatment market,” Celltrion said in a statement,”

In addition to Remsima, currently sold in the US and Europe, Celltrion sells biosimilar versions of Herceptin and Rituxan in Europe. Last week, the firm’s Rituxan biosimilar, Truxima, was granted marketing approval by the US Food and Drug Administration, becoming the first-ever Rituxan copy to hit the US market.

By Sohn Ji-young (jys@heraldcorp.com)