Celltrion Receives European Approval for Stelara Biosimilar "QOYVOLMA"

Synergy Expected with Main Brand "Stekima"

Yonhap News

Celltrion announced on June 9 that its biosimilar for the autoimmune disease treatment Stelara (STELARA, ustekinumab), named QOYVOLMA (QOYVOLMA, CT-P43), has received marketing authorization from the European Commission (EC).

QOYVOLMA has been approved with an expanded indication compared to Celltrion's previously authorized Stelara biosimilar, Stekima. In addition to existing indications such as plaque psoriasis, psoriatic arthritis, and Crohn's disease (CD), QOYVOLMA has also been approved for ulcerative colitis (UC). With this, Celltrion now has two Stelara biosimilars in its portfolio.

Celltrion plans to strategically utilize these two products, each with different indications, to flexibly respond to the complex patent environment in various European countries and thereby expand its market share. In particular, with Stekima experiencing rapid growth in Europe since its launch, the addition of QOYVOLMA is expected to further expand indication coverage and strengthen competitiveness in the ustekinumab market.

Stekima is a new biosimilar therapy that was launched in Europe in November last year and in the United States in March this year. In Europe, it has been introduced in the five major markets (Germany, Spain, the United Kingdom, Italy, and France) as well as in the Netherlands, and has begun to aggressively target the market by winning bids immediately upon launch. In the United States, Celltrion has secured coverage by signing contracts with two of the top five pharmacy benefit managers (PBMs), which together account for about 90% of the total insurance market, and is in negotiations with other PBMs as well.

Celltrion stated that it will continue to expand its market share in the global ustekinumab market to drive revenue growth. According to pharmaceutical market research firm IQVIA, the global ustekinumab market was estimated to be worth approximately $21.66 billion (about KRW 30.3248 trillion) as of last year.

A Celltrion representative said, "With this approval of QOYVOLMA, we will be able to further strengthen our coverage in the European ustekinumab market. Since Stekima, which was launched earlier, is already showing positive growth trends in Europe and other global ustekinumab markets, we will do our best to leverage the complementary characteristics of both products to expand our market share and drive revenue growth."

This content was produced with the assistance of AI translation services.