Celltrion's Remsima gets regulatory nod in 100 countries

Celltrion's authorized biomedicine 'Remsima' (Celltrion)

South Korean drug maker Celltrion said Tuesday its antibody biosimilar Remsima has received authorization from 100 countries worldwide, a feat achieved almost 10 years after its getting approval at home.

Remsima is a TNF-α inhibiting antibody biosimilar used to treat autoimmune diseases such as rheumatoid arthritis, ulcerative colitis, and Crohn’s disease. The drug got its first approval from Korea’s Ministry of Food and Drug Safety in 2012.

Since then, the biosimilar received regulatory approvals in key markets, including the US and Europe. As of the end of 2022, the number of countries has exceeded the 100 mark, the company said.

Over the past years, Remsima has continued expanding its presence globally. Its market share in Europe stood at 53.6 percent in the second quarter last year. In the US, the drug, sold through Pfizer, held a 31.7 percent market share in the third quarter.

“Research work for Remsima started in a very limited environment where biosimilars were still in their nascent stage,” said a company official. “We will continue ramping up efforts for the approval of other antibody treatments such as Truxima and Herzuma and to expand new product lineups.”

By Yu Ji-soo(jisooyu123@heraldcorp.com)