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Celltrion’s Steqeyma Receives Key Recommendation from European Medicines Agency

Biosimilar to Stelara poised for European market entry, bolstering Celltrion's global expansion efforts
South Korea
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Celltrion announced on July 1 that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) for its biosimilar Steqeyma, a treatment for autoimmune diseases. Steqeyma is designed as a biosimilar to Stelara (ustekinumab), a widely used medication in the treatment of autoimmune conditions.

The CHMP’s recommendation is a critical step towards securing final approval from the European Commission (EC), which Celltrion expects to obtain without major hurdles. This approval will pave the way for Steqeyma’s introduction to the European market, setting the stage for its broader global expansion.

Following European approval, Celltrion anticipates a swift entry into the global ustekinumab market, which was valued at approximately 26.42 trillion won ($19.58 billion) in 2023, according to IQVIA. Industry analysts highlight that the addition of Steqeyma to Celltrion’s portfolio, which includes therapies targeting interleukin (IL) inhibitors and tumor necrosis factor (TNF)-α inhibitors, will significantly expand the range of treatable conditions and target patient groups.

Celltrion has already secured sales approval for Steqeyma from the Korean Ministry of Food and Drug Safety (MFDS) for all indications of the original drug and is preparing for its launch in the Korean market. The company is also diligently advancing approval processes in other major markets, aiming to establish a strong global presence for Steqeyma.

 

 

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