World’s first biosimilar antibody* is approved in Korea

South Korean biosimilar manufacturer Celltrion, today declared that, Korean Food and Drug Administration approved its first biosimilar monoclonal antibody, Remsima.

Remsima is a biosimilar version of Remicade, the blockbuster in Rheumatoid Arthitis (RA). Korean FDA approved the product in several indications including RA, ankylosing spondylitis, ulcerative colitis, psoriasis and Crohn’s disease.

Celltrion already made an application for Remsima in the EU and according to Celltrion press release, the product will be launched in many countries in Asia, South America by the end of this year.

Remsima’s clinical results were announced in the latest European League Against Rheumatism (EULAR) congress in Berlin, Germany.

*: As Korean regulations are inline with global biosimilar guidelines, Remsima can be considered as “world’s first biosimilar antibody”. Back in 2007, Reditux was approved in India as a biosimilar version of Mabthera but India’s guidelines were not inline with the globally accepted biosimilar development rules and although the product is still on the market in some countries, it is not launched worldwide, yet.

Source: Celltrion press release