The Korea Herald


Celltrion's Stelara biosimilar recommended for EU approval

By Shim Woo-hyun

Published : July 1, 2024 - 16:53

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Celltrion's headquarters in Yeonsu-gu, Incheon (Celltrion) Celltrion's headquarters in Yeonsu-gu, Incheon (Celltrion)

Celltrion said Monday that CT-P43, its ustekinumab biosimilar referencing Stelara, received an approval recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use.

Stelara is Janssen's top-selling drug for psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. The global market for ustekinumab last year was estimated at around $20 billion, Celltrion added.

“CHMP’s recommendation plays a decisive role in the EMA’s final approval,” Celltrion said in expressing hopes for its biosimilar product to clear regulatory approval in Europe.

In South Korea, CT-P43 is preparing for domestic launch after receiving the marking approval from the Ministry of Food and Drug Safety last month.

“With the drug’s launch both here and in Europe, Celltrion will be able to accelerate its expansion in the global ustekinumab market,” an official from Celltrion said. “The company will increase its efforts to speed up CT-P43’s overseas launches.”

Receiving the recommendation is the latest outcome of Celltrion’s efforts to introduce new biosimilar products in overseas markets.

In May, Celltrion’s Omlyclo (CT-P39), an omalizumab biosimilar referencing Novartis’ Xolair, received the European Commission’s approval, becoming the first and only omalizumab biosimilar approved in Europe.

The Korean biopharmaceutical firm is currently awaiting European approval for CT-P42, an aflibercept biosimilar referencing Regeneron's Eylea. Celltrion submitted a marketing authorization application for CT-P42 to the EMA in November last year.

Celltrion is also conducting clinical studies for new biosimilar candidates for their future launches.

On Friday, Celltrion said in its regulatory filing that the company has sent its application to the US Food and Drug Administration to conduct a phase 3 clinical trial for CT-P55, Celltrion's new biosimilar candidate referencing Novartis' psoriasis treatment Cosentyx (secukinumab).

Celltrion currently aims to launch additional biosimilar pipelines to expand its biosimilar portfolio to 11 by 2025, in a bid to become a global biosimilar producer.