Celltrion received approval from the Polish Pharmaceutical and Medical Equipment Registration Office (URPL) on Monday for the phase 3 clinical trial (IND) of its Actemra biosimilar, "CT-P47," which treats rheumatoid arthritis treatment.

Celltrion won the investigational new drug (IND) approval two months after applying for a phase 3 clinical trial plan for CT-P47 to the URPL and will conduct it on 448 rheumatoid arthritis patients in Europe. In addition, the company plans to conduct comparative studies on the efficacy, safety, pharmacokinetics, and immunogenicity of CT-P47 and the original drug, Acterma (ingredient: tocilizumab), through the upcoming trials.

Celltrion began phase 1 trials in July last year, completed its dosing, and is analyzing the results.

The original drug Actemra is an interleukin formulation that reduces inflammation by inhibiting the interleukin-6 protein involved in causing inflammation in the body. It is used to treat rheumatoid arthritis, systemic juvenille idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, and cytokine release syndrome.

Last year, the drug recorded 4.56 trillion won ($3.4 billion) in global sales.

Celltrion is developing CT-P47 in two formulations -- subcutaneous injection (SC) and intravenous injection (IV) – to help medical professionals selectively prescribe them, considering the patient’s conditions and convenience.

"We plan to build a variety of product lines in the global autoimmune disease market by taking the lead from our TNF-α inhibitor drug, Remsima,” an official from Celltrion said, “We will continue to develop interleukin inhibitor biosimilars, such as Actemra, and do our best to speed up CT-P47 global phase 3 clinical trials.”

Celltrion plans to license more than one drug every year by 2030. Last month, its Avastin biosimilar Vegzelma (CT-P16), a treatment for metastatic colorectal cancer, obtained a sales approval recommendation from the European Medicines Agency Committee for Medicinal Products for Human Use (EMA CHMP).

The company expects to receive approval from the U.S. FDA for its Humira biosimilar Yuflyma (CT-P17) this year.

출처 : KBR(http://www.koreabiomed.com)