Celltrion's CT-P47 approved for Phase 3 trials in Poland

Celltrion won approval to start Phase 3 clinical trials of CT-P47, its biosimilar version of rheumatoid arthritis treatment Actemra, in Poland.

The drug is an identical copy of tocilizumab, better known as Actemra, developed by Switzerland's Roche. Actemra is used to treat adults with moderately to severely active rheumatoid arthritis after at least one other medicine has been used and did not work well.

The Phase 3 clinical trials will be conducted on 448 patients in Europe, to test its safety, efficacy and immunogenicity compared to the original drug.

Actemra alone generated 4.56 trillion won ($3.5 billion) in global sales last year.

Biosimilars, according to the U.S. Food and Drug Administration (FDA), are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically meaningful differences in terms of safety or effectiveness from the reference product, but they cost less.

BY SARAH CHEA [chea.sarah@joongang.co.kr]