Celltrion receives positive CHMP Opinion for SteQeyma™ (ustekinumab biosimilar) autoinjector

SteQeyma™45mg and 90mg solution for injection via autoinjector (pre-filled pen) receives positive CHMP opinion, which will facilitate subcutaneous administration in patients with plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease (CD)1The new autoinjector option increases convenience, enhances individual patient experience and expands administration options

Celltrion, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of autoinjector of SteQeyma™, a biosimilar to Stelara^® (ustekinumab), for the treatment of plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease (CD).

The positive CHMP opinion is for SteQeyma autoinjector in 45mg/0.5mL and 90mg/1mL, expanding the currently approved SteQeyma™ presentation, which includes 45mg/0.5mL, 90mg/1mL in a pre-filled syringe and 45mg/0.5mL in a vial for subcutaneous injection, as well as 130mg/26mL concentrate for solution for intravenous infusion.

“The new SteQeyma™ autoinjector brings together convenience and practical usability to meet the everyday challenges faced by patients living with chronic inflammatory diseases. 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,” said Taehun Ha, Senior Vice President and Head of Europe Division at Celltrion. “This marks an important milestone in strengthening Celltrion’s immunology portfolio and reaffirms our pioneering leadership in the global biosimilar sector, as we remain committed to reducing the healthcare burden, improving patients’ quality of life, and enhancing the overall patient experience.”

With this new addition, SteQeyma™ broadens the administration option, giving patients and physicians access to a complete range of administration options. The new SteQeyma™ autoinjector enables patients and caregivers to administer the medicine via a simple two-step process. The device includes two clear visual and audible indicators - a viewing window and audible clicks to support patients easily identify the injection status, which guide patients with successful administration. SteQeyma™ autoinjector is citrate-free with special thin-wall needle technology to help reduce injection pain. It also offers a 4-year shelf life and can be re-refrigerated, helping reduce product disposal.

SteQeyma™ is currently licensed in more than 40 countries worldwide, including the US, Japan and EU countries. Alongside Remsima™ SC, a subcutaneous formulation of infliximab approved in the EU, SteQeyma™ joins Celltrion’s distinguished portfolio that includes Remsima™ (biosimilar infliximab), Truxima™ (biosimilar rituximab), Herzuma™ (biosimilar trastuzumab), Yuflyma™ (biosimilar adalimumab), Vegzelma™ (biosimilar bevacizumab), Omlyclo™ (biosimilar omalizumab), Avtozma™ (tocilizumab biosimilar), Osenvelt/Stoboclo™ (biosimilar denosumab), Eydenzelt™ (biosimilar aflibercept) and Remsima™ (biosimilar infliximab) IV liquid formulation.

Notes to Editors:

About SteQeyma™ (CT-P43, biosimilar ustekinumab)¹

SteQeyma™, formerly known as CT-P43, is a human IL-12 and IL-23 antagonist indicated for multiple immune-mediated diseases. SteQeyma™ is available in both subcutaneous and intravenous formulations. The subcutaneous injection comes in two strengths: 45mg/0.5 mL or 90mg/1 mL solution in a prefilled syringe and prefilled pen, as well as 45mg/0.5mL in a vial. The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a vial.

SteQeyma™ will be available as an autoinjector in 45mg/0.5mL and 90mg/1mL.¹ 
For plaque psoriasis and psoriatic arthritis, SteQeyma™ is administered at 45mg subcutaneous initially, followed by a 45mg dose 4 weeks later, and then every 12 weeks thereafter. For Crohn’s disease, the first dose is administered intravenously, followed by 90mg subcutaneous dose at week 8, and then every 12 weeks thereafter.

About Celltrion, Inc.

Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Built on trust through our fully integrated capabilities – from advanced R&D and in-house manufacturing to a reliable global supply network – we continue moving toward innovation as we work to ensure consistent availability of affordable, trusted, and high-quality biologics for patients and healthcare systems across Europe.

For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook.

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References

¹ European Medicines Agency. Summary of Product Characteristics (SmPC), SteQeyma. [Last Accessed December 2025]

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