Ustekinumab Biosimilar (Celltrion)

The European Commission (EC) has approved Celltrion’s SteQeyma (CT-P43), an ustekinumab biosimilar referencing Johnson & Johnson’s Stelara, to treat multiple chronic inflammatory diseases. The interleukin (IL)-12 and IL-23 antagonist has been authorised for use in gastroenterology, dermatology and rheumatology indications, and will be available in subcutaneous and intravenous formulations. A biosimilar, according to the European Medicines Agency (EMA), is a biological medicine that is highly similar to one already approved in the EU. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may benefit from lower healthcare costs. The EC’s decision on SteQeyma follows a recent recommendation from the EMA’s human medicines committee and is supported by a totality of evidence, including positive results from a phase 3 trial in adults with moderate-to-severe plaque psoriasis. Taehun Ha, senior vice president and head of Europe division at Celltrion, said: “The EC approval of SteQeyma brings an important new therapeutic option to patients and we’re excited to launch this innovative therapy, with a proven track record in Crohn’s and other immune diseases.” Ha added that the approval “marks a key milestone” in Celltrion’s strategy to strengthen its immunology offering, and that the company is “looking forward to expanding [its] portfolio into the dermatology sector”. SteQeyma is Celltrion’s seventh biosimilar authorised for use in the EU, following the approval of Omlyclo (CT-P39) in May. The omalizumab biosimilar referencing Novartis and Genentech’s Xolair was indicated for use in patients with allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps. The EC’s decision made Omlyclo the first omalizumab biosimilar to be approved in Europe and was based on clinical evidence including results from a global phase 3 trial, which compared Omlyclo against Xolair in patients with the skin condition CSU for up to 40 weeks. Celltrion also recently shared promising results from a late-stage study of its biosimilar candidate referencing Roche’s RoActemra (tocilizumab) in patients with moderate-to-severe rheumatoid arthritis. The comparative study demonstrated that the investigational drug, CT-P47, was highly similar in terms of efficacy and safety to the reference product up to week 32.

INCHEON, South Korea I August 25, 2024 I Celltrion today announced that the European Commission (EC) has approved the use of SteQeyma ® (CT-P43), an ustekinumab biosimilar referencing Stelara ® , for the treatment of multiple chronic inflammatory diseases. SteQeyma is approved as a biologic therapy in gastroenterology, dermatology and rheumatology indications. 1 Stelara was the first biologic therapy for Crohn’s disease to target interleukin (IL)-12 and IL-23 cytokines, known to play a key role in inflammatory and immune responses. 2 The decision from the EC follows a positive opinion recommending SteQeyma from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2024. 3 The EC approval of SteQeyma was based on the totality of evidence, including the results from a Phase III study in adults with moderate to severe plaque psoriasis, in which the primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. The clinical results demonstrated that SteQeyma is highly similar to its reference product, Stelara, and has no clinically meaningful differences in terms of efficacy and safety. 4,5 “The EC approval of SteQeyma brings an important new therapeutic option to patients and we’re excited to launch this innovative therapy, with a proven track record in Crohn’s and other immune diseases,” said Taehun Ha, Senior Vice President and Head of Europe Division at Celltrion. “This approval, alongside those of Remsima SC and Yuflyma, marks a key milestone in our strategy to strengthen Celltrion’s immunology offering, and with the recent approval of Omlyclo in May, we are looking forward to expanding our portfolio into the dermatology sector. We believe the approval demonstrates our unwavering commitment to expanding patient access to affordable, high-quality biologic medicines.” SteQeyma is Celltrion’s seventh biosimilar approved for use in the European Union (EU). 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) and Omlyclo ® (biosimilar omalizumab). 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 single-dose, prefilled syringe. The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial. About Celltrion Celltrion is a leading biopharmaceutical company based in Incheon, South Korea that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people’s lives worldwide. The company’s solutions include world-class monoclonal antibody biosimilars such as Remsima ® , Truxima ® and Herzuma ® , providing broader patient access globally. Celltrion has also received U.S. FDA and EC approval for Vegzelma ® , Yuflyma ® and Omlyclo ® , FDA approval for Zymfentra ® , and EC approval for Remsima ® SC. To learn more, please visit www.celltrion.com/en-us . Trademark Stelara ® is a registered trademark of Johnson & Johnson. SteQeyma ® is a registered trademark of Celltrion, Inc., used under license. References 1 European Medicines Agency Summary of Product Characteristics (SmPC), SteQeyma. 2 European 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]. 3 European Medicines Agency. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 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 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, 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., Efficacy and Safety after Switch from Reference Ustekinumab to Ustekinumab Biosimilar (CT-P43) in comparison with the Maintenance Group (CT-P43 or Reference Ustekinumab) in Patients with Moderate-to-Severe Plaque Psoriasis: 1-Year Result. [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]. SOURCE: Celltrion