Celltrion received a positive opinion for marketing its subcutaneous-type Remsima from the Committee for Medicinal Products for Human Use of the European Medicines Agency, the company said Monday.

A CHMP positive opinion usually indicates that the company will eventually gain EMA‘s approval, Celltrion said, making vows to dominate the 45 trillion won ($ 37.7 billion)-size TNF-alpha inhibitor market by 2038.

Celltrion has applied for a patent for Remsima SC in approximately 130 countries. 




Subcutaneous type Remsima, or Remsima SC, is an under-the-skin injection type form of the infliximab biosimilar that is easier to administer than the previous intravenous type.

Celltrion had applied for approval from EMA under the biobetter category which means the biosimilar is a better version of the original drug.

Remsima can treat autoimmune diseases such as Crohn’s disease and rheumatoid arthritis.

“Today’s positive CHMP opinion brings us one step closer to providing personalized treatment for people with rheumatoid arthritis,” said Kim Hyoung-ki, Vice Chairman of Celltrion Healthcare, which oversees the direct and indirect sales of the drug.

“If approved, we will begin a new era in the biotherapeutic class, as Remsima SC (CT-P13 SC) would be the world’s first subcutaneous version of infliximab, expanding the treatment options for physicians and their patients,” Kim said.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)