Celltrion, which is developing CT-P47, the biosimilar of Actemra (tocilizumab), has set about to diversify its formulation.
According to informed sources, Celltrion received approval from the Ministry of Food and Drug Safety for the domestic phase 1 clinical trial of CT-P47, which treats rheumatoid arthritis, on Sept. 28.
Its objective is to compare and evaluate the pharmacokinetics and safety of CT-P47’s two subcutaneous injection (SC) formulations. Celltrion, which is conducting CT-P47’s intravenous (IV) formulation and original drug Actemra through phase 3 trials in the U.S. and Poland, has begun to accelerate the development of SC formulations.
Four medical institutions – Seoul National University Hospital, Gachon University Gil Medical Center, Chungbuk National University Hospital, and Jeonbuk National University Hospital – will conduct the phase 1 trial by attracting up to 268 patients.
Celltrion plans to start phase 1 trials in earnest this month and complete them by next April.
It is noteworthy that the company has begun to develop an auto-injector (AI) formulation, as was the case with the original Actemra.
Celltrion plans to check the pharmacokinetics and safety of CT-P47’s AI formulation by using CT-P47’s prefilled syringe (PFS), which underwent safety and equivalence evaluation compared to Actemra in previous domestic phase 1 clinical trial, as the control drug.
Commenting on the development of AI and SC formulations of the Actemra biosimilar, Celltrion said it is based on the company’s strategy to expand prescribing options and enhance patient convenience.
However, the company added that it has yet to decide to complete developing both AI and PFS formulations.
“We are developing IV formulation in Europe and two SC formulations – AI and PFS -- in Korea. There may be a difference in the order of clinical trials, but our goal of releasing various formulations is the same,” a company official said.
Acknowledging that the AI formulation of CT-P47 can hardly be regarded as a bio better, the official said, “We hope consumers will understand it as an effort to develop diverse formulations to help physicians describe SC formulations according to patients’ circumstances. However, as it is still in the early stage of development, it is too early to talk about plans to apply for their approval, much less market release.”
Actemra is an autoimmune disease treatment based on the interleukin-6 (IL-6) mechanism. It is also used to treat full-body-type pediatric idiopathic arthritis, polyarticular pediatric idiopathic arthritis, giant cell arteritis, and cytokine release syndrome.
Its global sales totaled 3.56 billion Swiss francs (about 4.56 trillion won) last year.