European Commission Approves Celltrion's SteQeyma ® (CT-P43), a Biosimilar to Stelara ® (ustekinumab), for Use in the Treatment of a Number of Chronic Inflammatory Diseases

SteQeyma ^® (CT-P43) is a biologic approved for use in the gastroenterological, dermatological and rheumatological fields ^.
European Commission (EC) approval based on comprehensive evidence, including results from a Phase III study in adult patients with moderate to severe plaque psoriasis
Celltrion is focused on expanding its biosimilars portfolio while building expertise in immunology

August 25, 2024 07:05 PM Eastern Daylight Time

INCHEON, South Korea–( BUSINESS WIRE )–Celltrion announced that the European Commission (EC) has approved the use of SteQeyma ^® (CT-P43), a biosimilar of ustekinumab, the predecessor to Stelara ^® , for the treatment of a number of chronic inflammatory diseases. SteQeyma ® is an approved biologic with indications in the fields of gastrointestinal, dermatological and rheumatic diseases.1 Stelara ^® is ^the^first^biologic to target interleukin (IL)-12 and IL-23 cytokines, known to play key roles in inflammation and immune responses, in the treatment of Crohn’s ^disease.2

The EC received a positive opinion recommending the approval of SteQeyma® from the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) in June 2024, leading ^to^this approval.3

The EC’s approval of SteQeyma ^® was based on a comprehensive body of evidence, including results from a Phase III study in adults with moderate to severe plaque psoriasis, with the primary endpoint being percent change in the Psoriasis Area and Severity Index (PASI). The results showed that SteQeyma ® was highly ^comparable to its predecessor, Stelara ^® , with no clinically meaningful differences in efficacy or safety. ^4,5

Ha Tae Hoon, Senior Vice President and Head of Europe at Celltrion, said, “The approval of SteQeyma ^{® by the European Commission provides patients with an important new treatment option. We are very pleased to introduce this proven treatment to the market in Crohn’s disease and other immune disorders. Alongside Remsima}^® SC and Yuflyma ^® , this approval marks an important milestone in our strategy to strengthen our contributions in the immunology field. We are also pleased to expand our portfolio into dermatology, following the approval of Omlyclo ^® in May this year. We believe this approval underscores our firm commitment to expanding access to affordable, high-quality biopharmaceuticals for more patients.”

SteQeyma ^® is Celltrion’s seventh biosimilar approved in the European Union. Along with Remsima ^® SC, a subcutaneous injection of infliximab approved in the European Union, SteQeyma joins Celltrion’s portfolio which also includes Remsima ^® (biosimilar infliximab), Truxima ^® (biosimilar rituximab), Herzuma ^® (biosimilar trastuzumab), Yuflyma ® ^{( biosimilar adalimumab), Vegzelma}^® (biosimilar bevacizumab) and Omlyclo ^® (biosimilar omalizumab).

About SteQeyma® ⁽ CT-P43, a biosimilar to ustekinumab) ¹

SteQeyma ^® (CT-P43) is a human interleukin-12 (IL-12) and interleukin-23 (IL-23) antagonist, indicated for a number of immune-mediated diseases. SteQeyma ^® is available for subcutaneous and intravenous administration. Subcutaneous administration is available in two doses, 45 mg/0.5 mL or 90 mg/1 mL, administered in a single-use prefilled syringe. Intravenous administration is available in a single-use vial, at 130 mg/26 mL (5 mg/mL).

About Celltrion

Celltrion is a leading biopharmaceutical company based in Incheon, Korea, dedicated to the research, development, manufacturing, marketing and sale of innovative therapeutics that improve the quality of people’s lives worldwide. The company offers world-class monoclonal antibody biosimilar solutions including Remsima ® ^, Truxima ^® and Herzuma ^® , providing broad medical treatment to patients around the world. Celltrion has also received U.S. FDA and European Commission approvals for Vegzelma ^® , Yuflyma ^® and Omlyclo ^® , U.S. FDA approval for Zymfentra ^® , and European Commission approval for Remsima ^® SC . For more information, please visit www.celltrion.com/en-us .

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The forward-looking statements contained in this presentation have been made by the management of Celltrion Co., Ltd. and its subsidiaries based on their reasonable judgment, but the reader is cautioned that actual results and future events may differ materially from those anticipated in such statements. Celltrion Co., Ltd. and its subsidiaries undertake no obligation to update forward-looking statements, even if circumstances or management’s estimates or opinions should change, except as required by applicable securities laws. Readers are cautioned not to place undue reliance on forward-looking statements.

trademark

Stelara ^® is a registered trademark of Johnson & Johnson.
SteQeyma ^® is a registered trademark of Celltrion and is used under license.

References

^1European Medicines Agency . Summary of Product Characteristics (SmPC), STELARA Available at: https://www.ema.europa.eu/en/documents/product-information/stelara-epar-product-information_en.pdf . [Last accessed August 2024]. ^3European
^Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) Meeting Highlights 24-27 June 2024. Available at: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2024 . [Last accessed August 2024]. ⁴ Papp KA et al. Efficacy and safety of candidate biosimilar CT-P43 vs original ustekinumab in moderate-to-severe plaque psoriasis: 28-week results from a randomized, active-controlled, double-blind phase III study. BioDrugs. 2023. Available at: https://link.springer.com/article/10.1007/s40259-023-00630-5 . [Last accessed August 2024]. ⁵ Papp K et al. One-year efficacy and safety of switching from reference ustekinumab to ustekinumab biosimilar (CT-P43) compared with maintenance treatment (CT-P43 or reference ustekinumab) in patients with moderate-to-severe plaque psoriasis. [EADV 2023, Abstract #4035]. Available at: https://eadv.org/wp-content/uploads/scientific-abstracts/EADV-congress-2023/Biologics-immunotherapy-targeted-therapy.pdf . [Last accessed August 2024].

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