Celltrion applies for Phase 3 clinical trials in Europe for biosimilar

The S.Korean company’s CT-P53 is based on the multiple sclerosis treatment Ocrevus

Celltrion applies for Phase 3 clinical trials in Europe for biosimilar
Jeong Min Nam 1
2023-05-03 10:22:18 peux@hankyung.com
Bio & Pharma

South Korea’s Celltrion Inc. is speeding up global clinical trials of its biosimilar of the multiple sclerosis (MS) treatment Ocrevus (active ingredient ocrelizumab).

The company on Tuesday said it submitted an investigational new drug application for Phase 3 clinical trials for the Ocrevus biosimilar CT-P53 to the Clinical Trials Information System of the European Medicines Agency. Global testing of CT-P53 is conducted in Europe only, but expansion to the US is planned.

Ocrevus is a blockbuster medicine for autoimmune disease developed by global pharmaceutical giant Roche. With sales of 9 trillion won ($6.7 billion) last year, the drug is mainly used to treat relapsing or primary-progressive MS.

“This application for global Phase 3 clinical trials has raised our competitiveness in the pipeline (candidate material) for autoimmune disease treatment,” a Celltrion source said.

Write to Jeong Min Nam at peux@hankyung.com
#Celltrion #multiple sclerosis #Ocrevus #biosimilar #CT-P53 #Phase 3 #clinical trials #Europe

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