Celltrion announced on June 9 that its biosimilar of Stelara (Ustekinumab), Qoyvolma (development code: CT-P43), has received approval from the European Commission (EC).
Qoyvolma is an extension of Celltrion’s existing Stelara biosimilar Steqeyma, which has already been approved for indications including plaque psoriasis, psoriatic arthritis, and Crohn’s disease. With regulatory clearance, Qoyvolma now includes additional authorization for ulcerative colitis, broadening its approved uses. As a result, Celltrion has secured two biosimilars targeting the Stelara market.
Leveraging the differentiated indications of both products, Celltrion plans to strategically navigate the complex patent landscape across European countries to expand its market share. Since Steqeyma’s European launch, which has experienced rapid growth, the addition of Qoyvolma is expected to further enhance the competitiveness of Ustekinumab biosimilars in Europe.
Steqeyma was launched in November last year in Europe and in March this year in the United States. In Europe, the biosimilar secured bids and contracts in five major countries and the Netherlands, marking a strong market entry. In the U.S., it has signed agreements with two of the top five pharmacy benefit managers (PBMs) to secure insurance coverage, with negotiations ongoing with others.
Celltrion aims to steadily expand its share of the global Ustekinumab market, which is projected to reach approximately $21.66 billion in 2024, according to market research firm IQVIA.
A Celltrion representative stated, “The approval of Qoyvolma in Europe significantly broadens Ustekinumab market coverage. We will leverage the positive growth trend of Steqeyma and the complementary features of both products to maximize market share and drive sales growth.”
