Celltrion announced on the 9th that its autoimmune disease treatment drug Stelara (STELARA; ingredient name ustekinumab) biosimilar Qoyvolma has received product approval from the European Commission (EC).
Qoyvolma has received approval by adding ulcerative colitis (UC) to the existing approved Stelara biosimilar Steqeyma's treatment indications, which include plaque psoriasis, psoriatic arthritis, and Crohn's disease (CD). Both Qoyvolma and Steqeyma contain the ingredient ustekinumab from Stelara, but Steqeyma has been developed for the U.S. market, while Qoyvolma is specialized for the European market with different treatment indications.
This allows Celltrion to secure a total of two Stelara biosimilars. Stelara is an autoimmune disease treatment drug from Johnson & Johnson (J&J) in the United States.
Celltrion plans to strategically utilize the two products with different treatment indications to expand its market share in Europe. In particular, as Steqeyma has been rapidly growing since its launch in Europe, the approval of Qoyvolma, which expands the treatment indications, is expected to enhance competitiveness within the ustekinumab market.
Steqeyma is a new biosimilar treatment that was launched in Europe in November last year and in the United States in March this year. In Europe, it has been launched in major five countries (Germany, Spain, the United Kingdom, Italy, France) as well as in the Netherlands, and it secured contracts immediately upon release. Celltrion signed contracts with two of the top five pharmacy benefit managers (PBM) that account for about 90% of the total insurance market in the United States, and negotiations are ongoing with other PBMs.
Celltrion aims to continue expanding its market share in the global ustekinumab market and drive sales growth. According to the pharmaceutical market research firm IQVIA, the global market size for ustekinumab is estimated to be approximately $21.6606 billion (30.3248 trillion won) in 2024.
A Celltrion official noted, "Since Steqeyma, which was launched earlier, is already showing positive growth trends in the global ustekinumab market, including Europe, we will do our best to leverage the complementary characteristics of the two products to expand market share and translate that into sales growth."