Celltrion Voluntarily Withdraws Marketing Authorization for Ustekinumab Biosimilar, Qoyvolma, in Europe.
Streamlining Marketing Efforts Through Redundant Marketing Authorization Management
Celltrion's Hungarian subsidiary has applied to the European Medicines Agency (EMA) to withdraw the marketing authorization for Qoyvolma, its ustekinumab biosimilar product, an interleukin-12/23 (IL-12/23) inhibitor. This is a commercial decision to consolidate its product lineup by eliminating overlap with its existing biosimilar, Steqeyma, and is not related to any safety or efficacy concerns. Celltrion received approval from the European Commission (EC) on June 2, 2025, but has decided to finalize the withdrawal on June 12, 2026, to streamline distribution and focus marketing resources.
Targeting the European Market with a Single Steqeyma Brand
This action reflects a commercial decision to reduce product management costs and administrative fees in the European market and maximize single-brand power. Qoyvolma was a duplicate application product approved for patent circumvention and distribution strategy and has not been launched in Europe. Celltrion plans to prevent confusion caused by operating multiple brands and concentrate all its resources on Steqeyma to accelerate market penetration.
Fierce Competition with the Originator, Stelara
Stelara, the originator drug developed by Janssen, recorded global sales of approximately $10.36 billion in 2024, but this figure is expected to drop to approximately $6.08 billion in 2025 due to patent expiration and the entry of biosimilars. Steqeyma is strengthening its efforts to target the European market for all indications of Stelara, including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Celltrion is leveraging its price competitiveness and prescription reliability to quickly capitalize on the market gap created by the originator's patent expiration.
Intensifying Competition in the European Ustekinumab Market
Currently, the European ustekinumab market is highly competitive, with biosimilars from global pharmaceutical companies entering the market. Uzpruvo from Alvotech and Stada was the first to receive approval, and other competitive products such as Pyzchiva from Samsung Bioepis and Otulfi from Formycon are also competing. In this context, Celltrion's brand consolidation is a strategic decision to prevent the dispersion of marketing resources and rapidly increase Steqeyma's market share.
Reducing Healthcare Costs and Improving Patient Access
The European biosimilar market is tender-based, so demonstrating supply stability through a single brand is very important. Operating a single brand, as opposed to multiple brands, simplifies the supply chain and helps to respond flexibly to pressure to lower drug prices. As a result, Celltrion is expected to eliminate waste of resources, enhance its cost competitiveness, and continue to expand its presence in Europe.
This voluntary withdrawal of marketing authorization is a brand consolidation measure that occurred in the European ustekinumab biosimilar approval and launch phase, and it is not related to safety issues, so it will not have a negative impact on the company's value. In a competitive landscape where Steqeyma competes with leading competitors such as Uzpruvo and Pyzchiva to gain market share in the Stelara market, which has global sales of approximately $6.08 billion (as of 2025), streamlining marketing resources will accelerate efficiency. Eliminating fees and administrative costs associated with maintaining duplicate products will contribute to improved operating profit margins and will directly enhance the competitiveness of the single brand, Steqeyma, in European tenders. In the long term, it is expected to create synergistic effects by unifying the global brand identity of Steqeyma, which has entered the U.S. FDA approval (Marketed) stage, and integrating commercialization efforts. From an investor's perspective, optimizing cost structure to defend profitability and the pace of Steqeyma's market share expansion in the European tender market will be key indicators for medium- to long-term corporate value creation.
Source: EMA (ema)