Celltrion files IND for Phase 3 study of Actemra biosimilar in Poland

[Source: Celltrion Inc.]

South Korea’s Celltrion Inc. has submitted an investigational new drug (IND) application to Polish health authorities (URPL) to evaluate its Actemra (tocilizumab) biosimilar in a planned Phase 3 clinical trial.

Celltrion’s biosimilar codenamed CT-P47 is being developed in two formulations – intravenous and subcutaneous – like its reference drug from Roche, which is widely used to treat rheumatoid arthritis (RA) across the world.

The randomized, double-blind, and active-controlled study will enroll a subset of 448 RA patients in Europe to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of CT-P47 for 13 months, the Korean drug giant said in a regulatory filing on Tuesday.

The company said it aims to file a new drug application (NDA) for CT-P47 in the first half of 2024 based on the pivotal study.

Celltrion shares gained 1.06 percent to trade at 142,500 won ($112) on Tuesday.

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