Celltrion's SteQeyma Autoinjector Gains Key EU Nod, Boosting Patient Convenience and Market Competition

INCHEON, South Korea – December 17, 2025 – In a move set to enhance treatment options for patients with chronic inflammatory diseases, Celltrion announced it has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for an autoinjector version of SteQeyma™, its biosimilar to Stelara® (ustekinumab).

This regulatory milestone paves the way for a more convenient administration option for patients managing conditions like plaque psoriasis, psoriatic arthritis, and Crohn's disease. The positive opinion covers both 45mg and 90mg doses of the autoinjector, expanding upon SteQeyma's existing presentations, which include pre-filled syringes and vials for subcutaneous or intravenous use. Following the CHMP's recommendation, a final marketing authorization from the European Commission is expected within the next few months.

This development is not just a product line extension; it represents a significant step in empowering patients and sharpening Celltrion's competitive edge in a fiercely contested market.

A New Era of Patient-Centric Treatment

For the millions of individuals living with chronic autoimmune diseases, long-term treatment adherence is a constant challenge. The introduction of an autoinjector is designed to directly address this, simplifying the process of self-administration and improving the overall patient experience. Celltrion has engineered the SteQeyma™ autoinjector with user-friendliness at its core.

The device features a simple two-step process, guided by both visual and audible cues—a viewing window and distinct clicks—to confirm a successful injection. This design aims to reduce patient anxiety and the potential for user error. Furthermore, the formulation is citrate-free and administered via thin-wall needle technology, features specifically intended to minimize injection-related pain and discomfort, a common barrier to consistent treatment.

“The new SteQeyma™ autoinjector brings together convenience and practical usability to meet the everyday challenges faced by patients living with chronic inflammatory diseases,” said Taehun Ha, Senior Vice President and Head of Europe Division at Celltrion, in a statement. “The full range of our SteQeyma™ dosage forms and strengths, with the autoinjector now added, provides patients and healthcare professionals with more individualized treatment options that support ease of use and improve adherence.”

Beyond the immediate user benefits, the product offers practical advantages for supply management. A four-year shelf life and the ability to be re-refrigerated can help reduce waste and offer greater flexibility for both patients and pharmacies, a notable advantage in managing expensive biologic therapies.

Navigating a Crowded Biosimilar Battlefield

The approval of the SteQeyma™ autoinjector comes as the European market for ustekinumab biosimilars becomes increasingly crowded and competitive. The reference product, Johnson & Johnson’s Stelara®, has long been a blockbuster drug, and its patent expiry has opened the floodgates for a wave of biosimilar challengers. The European ustekinumab market is valued at approximately €2.5 billion, making it a lucrative prize for biopharmaceutical firms.

Celltrion is entering a field with several formidable competitors who have already launched their own ustekinumab biosimilars. Alvotech and STADA's Uzpruvo® was the first to gain European approval in January 2024, followed swiftly by products from Samsung Bioepis/Sandoz (Pyzchiva®) and Amgen (Wezenla™). By the end of 2025, the market is expected to feature at least seven to nine approved ustekinumab biosimilars, creating intense pressure on pricing and market share.

In this environment, differentiation is key. While biosimilars are by definition highly similar to the originator drug in terms of safety and efficacy, companies are competing on factors like price, supply reliability, and administration options. By offering a comprehensive suite of delivery methods—including vials, pre-filled syringes, and now a state-of-the-art autoinjector—Celltrion is strategically positioning SteQeyma™ to capture a significant share of the market by catering to diverse patient and provider preferences. This move is a core component of the company's broader strategy, which includes building a direct sales network across major European markets to enhance commercial agility and market penetration.

Driving Healthcare Sustainability and Access

The impact of this development extends far beyond patient convenience and corporate strategy. The proliferation of high-quality biosimilars like SteQeyma™ is a critical driver of economic sustainability for Europe's healthcare systems. Biologic drugs represent a substantial and growing portion of pharmaceutical expenditure, and the introduction of lower-cost biosimilars generates significant savings.

Budget impact analyses have projected that the adoption of ustekinumab biosimilars could save European healthcare systems hundreds of millions of euros. For example, one projection estimated potential savings of over €526 million across Germany, the UK, and Sweden over three years. These savings are not merely figures on a balance sheet; they free up vital resources that can be reinvested to fund other innovative treatments or expand patient access to care.

The competition spurred by biosimilars typically drives down the price of not only the new entrants but also the original reference product, creating a market-wide deflationary effect that benefits payers. As national health authorities continue to promote biosimilar uptake to manage budgets, the availability of patient-friendly options like the SteQeyma™ autoinjector can help accelerate this transition.

By offering a high-quality, cost-effective, and convenient treatment alternative, Celltrion’s latest innovation reinforces the dual promise of biosimilars: to improve the quality of life for individual patients while simultaneously strengthening the financial health and accessibility of the healthcare systems that serve them.