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  • Celltrion¡¯s Stelara biosimilar Qoyvolma gains EU approval
  • by Kim, Jin-Gu | translator Alice Kang | Jun 10, 2025 06:03am
Qoyvolma  is additionally approved following the approval of Steqeyma... secures approval of 2 Stelara biosimilar
¡±Ulcerative colitis has been newly added as an indication for Steqeyma, accelerating the company¡¯s penetration of the approximately KRW 30 trillion market.¡±
Celltrion announced on the 9th that ¡®Qoyvolma,¡¯ its biosimilar version of the autoimmune disease treatment Stelara (ustekinumab) has received marketing authorization from the European Commission (EC).

Qoyvolma has been approved with the addition of ¡ã'ulcerative colitis (UC)' to the existing indications of ¡®Steqeyma,' another Stelara biosimilar previously approved by Celltrion, which is indicated for ¡ãplaque psoriasis, ¡ãpsoriatic arthritis, and ¡ãCrohn's disease (CD). With this approval, Celltrion now holds two biosimilars of Stelara.

Celltrion plans to strategically leverage the two products with different indications to flexibly address the complex patent landscape across European countries and expand its
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