Omalizumab biosimilar (Celltrion)

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

Clinical data confirmed that SteQeyma is highly similar to Stelara, without any significant differences in efficacy and safety. Credit: pedro7merino/Shutterstock. The European Commission (EC) has approved Celltrion ‘s SteQeyma (CT-P43), a biosimilar to Stelara (ustekinumab), for treating various chronic inflammatory conditions. This approval, which encompasses gastroenterology, dermatology, and rheumatology indications, follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June this year. SteQeyma, previously known as CT-P43, acts as an antagonist to human IL-12 and IL-23, addressing multiple immune-mediated diseases. It is available in subcutaneous and intravenous formulations, with the subcutaneous injection offered in 45mg/0.5ml or 90mg/1ml strengths in a single-dose, prefilled syringe. The intravenous infusion is available as a 130mg/26ml (5mg/ml) solution in a single-dose vial. Stelara, the reference product for SteQeyma, is a biologic therapy targeting interleukin (IL)-12 and IL-23 cytokines, crucial in inflammatory and immune responses. See Also: AstraZeneca may pull plug on UK vaccine manufacturing plans Touchlight to supply GMP dbDNA for UK Zika vaccine study The EC’s decision is grounded on comprehensive evidence, including a Phase III trial in adults with moderate to severe plaque psoriasis. The study’s primary endpoint was the change rate in the Psoriasis Area and Severity Index (PASI) for skin symptoms. Clinical data confirmed that SteQeyma is highly similar to Stelara, without any significant differences in efficacy and safety. SteQeyma is claimed to be the seventh biosimilar of Celltrion to receive EU approval, joining a portfolio that includes Remsima SC, Remsima, Truxima, Herzuma, Yuflyma, Vegzelma, and Omlyclo. In May this year, the EC approved Omlyclo, a omalizumab biosimilar for reference product Xolair, to treat allergic conditions. Celltrion Europe Division senior vice-president and head Taehun Ha 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. “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.”