Celltrion secures EU approval for second Stelara biosimilar Qoyvolma

Celltrion said it has received marketing authorization from the European Commission (EC) for Qoyvolma, its second biosimilar referencing Stelara (ingredient: ustekinumab), a widely used treatment for autoimmune diseases.

Stelara, developed by Johnson and Johnson Innovative Medicine, treats various inflammatory diseases including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Stelara is one of the top-grossing biopharmaceuticals globally, with sales reaching $21.66 billion in 2024.

With this approval, Celltrion now holds two distinct biosimilars targeting ustekinumab, strengthening its competitive position in the global biologics market. Unlike Steqeyma, its previously approved Stelara biosimilar, Qoyvolma includes an additional indication for ulcerative colitis (UC), expanding its therapeutic coverage alongside existing indications such as plaque psoriasis, psoriatic arthritis, and Crohn’s disease (CD).

By deploying two biosimilars with overlapping but distinct label indications, Celltrion plans to strategically navigate Europe’s complex patent landscape. The dual-product strategy is expected to help the company maximize flexibility in market entry across the region, while aggressively expanding its share in the multi-billion-dollar ustekinumab space.

Steqeyma, launched in Europe in November 2024 and in the U.S. in March 2025, has rapidly gained traction in major markets. In Europe, the drug is already available in Germany, Spain, the U.K., Italy, France, and the Netherlands, among others. Celltrion secured immediate tender wins upon launch, demonstrating strong commercial momentum.

In the U.S., Stekima has achieved significant market access by securing contracts with two of the top five pharmacy benefit managers (PBMs), which collectively control nearly 90 percent of the U.S. formulary market. Negotiations with additional PBMs are currently underway.

“With the EC approval of Qoyvolma, we have significantly strengthened our coverage of the European ustekinumab market,” a Celltrion official said. “Given the promising growth trajectory of Stekima in both Europe and the U.S., we will fully leverage the complementary profiles of both products to drive market share expansion and boost revenue.”