Biotech company Celltrion Inc. said Monday it completed the first successful clinical trial of a biosimilar antibody drug for rheumatoid arthritis.
Celltrion said it has tested the new drug on 874 patients in 20 countries since last November. It has spent 200 billion won in the clinical experiments so far and plans to spend another 80 billion won.
The market for arthritis drugs is thought to be worth 20 trillion won ($18 billion).
 |
Celltrion CEO Seo Jung-jin |
“It demonstrated equivalence in our initial review of the clinical and paraclinical trials. No physical or chemical problems were found in the 35 categories of quality,” a Celltrion official said in a press conference in Seoul.
Biosimilar products are officially approved subsequent versions of biopharmaceutical products made by a different firm after the rights to the product expire.
Celltrion’s latest success is a biosimilar version of Johnson & Johnson’s Remicade, the global sales of which amounted to about 7 trillion won last year.
“We plan to begin sales of the product after getting approval from the Korea Food and Drug Administration within the first half of next year,” the company official said.
“We will also push for the drug’s registration in emerging markets starting the second quarter of next year and expand sales to a total of 140 countries.”
Celltrion is also developing a biosimilar version of the breast cancer drug Herceptin and plans to complete clinical trials in mid-December.
By Kim So-hyun (
sophie@heraldcorp.com)
