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Celltrion seeks approval for Actemra biosimilar in Europe

Collected: 2024.02.13

Distributed: 2024.02.14

Source: Go Direct

[Courtesy of Celltrion]

Celltrion Inc. announced Tuesday that it submitted an application to the European Medicines Agency (EMA) for the marketing authorization of CT-P47, a biosimilar of the autoimmune disease treatment Actemra (tocilizumab).

The application covers the entire range of indications for Actemra, including rheumatoid arthritis, giant cell arteritis, systemic juvenile idiopathic arthritis, and Covid-19 for which Actemra is used in Europe.

Actemra is an interleukin-6 (IL-6) inhibitor, which effectively reduces inflammation by suppressing the IL-6 protein responsible for inducing inflammation in the body.

Celltrion conducted phase 3 clinical trials for CT-P47 involving 471 patients with rheumatoid arthritis, confirming the biosimilar’s equivalence and similarity to Actemra.

In January, Celltrion also applied for product approval in the United States, with plans to seek authorization in other countries, including Canada.

Celltrion intends to launch CT-P47 in two formulations, subcutaneous and intravenous injections, providing flexibility for patients and healthcare providers.

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