A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of RT-111- RaniPill Capsule Containing Ustekinumab - Administered Orally to Healthy Volunteers

A prospective, single-center, open-label, phase 1 study evaluating the pharmacokinetics (PK) of ustekinumab administered via the RaniPill™ capsule ("RT-111").

开始日期2023-08-30

申办/合作机构

Rani Therapeutics Holdings, Inc.

NCT04673786 / Completed临床3期

A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Moderate to Severe Plaque Psoriasis

This study is a randomized, active-controlled, double-blind, phase 3 study to compare the efficacy and safety of CT-P43 to Stelara in patients with moderate to severe plaque psoriasis.

开始日期2021-01-11

申办/合作机构

Celltrion, Inc.

EUCTR2020-001045-39-EE / Unknown status临床3期

A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients with Moderate to Severe Plaque Psoriasis

开始日期2020-11-12

申办/合作机构

Celltrion, Inc.

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100 项与乌司奴单抗生物类似药 (Celltrion) 相关的专利（医药）

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项与乌司奴单抗生物类似药 (Celltrion) 相关的文献（医药）

2024-01-01·BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

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

Article

作者: Bae, Yunju ; Pyo, Tina ; Lee, Hyunseung ; Reich, Adam ; Jeon, Dabee ; Bartnicka-Maslowska, Katarzyna ; Kolinek, Joanna ; Jaworski, Janusz ; Baran, Wojciech ; Papp, Kim A ; Ko, Woori ; Narbutt, Joanna ; Andrashko, Yuriy ; Dudek, Anna ; Kwiek, Bartlomiej ; Trefler, Jakub ; Reznichenko, Nataliya ; Szepietowski, Jacek C ; Kim, Sunghyun ; Thaçi, Diamant ; Daniluk, Stefan ; Jung, Jinsun ; Lebwohl, Mark G

BACKGROUND:

CT-P43 is a candidate ustekinumab biosimilar in clinical development.

OBJECTIVES:

This paper aims to demonstrate equivalent efficacy of CT-P43 to originator ustekinumab in adults with moderate to severe plaque psoriasis.

METHODS:

This double-blind, phase III trial randomised patients (1:1) to receive subcutaneous CT-P43 or originator ustekinumab (45/90 mg for patients with baseline body weight ≤ 100 kg/> 100 kg) at week 0 and week 4 in Treatment Period I. Prior to week 16 dosing in Treatment Period II, patients receiving originator ustekinumab were re-randomised (1:1) to continue originator ustekinumab or switch to CT-P43; patients initially randomised to CT-P43 continued receiving CT-P43 (at weeks 16, 28 and 40). The primary endpoint of the trial was mean per cent improvement from baseline in Psoriasis Area Severity Index (PASI) score at week 12. Equivalence was concluded if confidence intervals (CIs) for the estimate of treatment difference were within pre-defined equivalence margins: ± 10% [90% CI; modified intent-to-treat set; Food and Drug Administration (FDA) approach] or ± 15% [95% CI; full analysis set for patients only receiving 45 mg doses in Treatment Period I; European Medicines Agency (EMA) approach]. Additional efficacy, pharmacokinetic, safety and immunogenicity endpoints were evaluated through week 52. Results to week 28 are reported here.

RESULTS:

In Treatment Period I, 509 patients were randomised (CT-P43: N = 256; originator ustekinumab: N = 253). The mean per cent improvement in PASI score at week12 was 77.93% and 75.89% for CT-P43 and originator ustekinumab, respectively (FDA approach); per the EMA approach, corresponding values were 78.26% and 77.33%. Estimated treatment differences were 2.05 (90% CI -0.23, 4.32) and 0.94 (95% CI -2.29, 4.16); equivalence was achieved for both sets of assumptions. Further efficacy parameters and pharmacokinetic, safety and immunogenicity outcomes were comparable between treatment groups, including after switching from originator ustekinumab to CT-P43.

CONCLUSIONS:

CT-P43 demonstrated equivalent efficacy to originator ustekinumab in patients with moderate to severe plaque psoriasis, with comparable pharmacokinetic, safety and immunogenicity profiles.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT04673786; date of registration: 17 December, 2020.

项与乌司奴单抗生物类似药 (Celltrion) 相关的新闻（医药）

2024-10-11

·Pharmaceutical Technology

South Korean company Dong-A ST wins FDA approval for Stelara biosimilar

Stelara is indicated for use in patients with active psoriatic arthritis as well as moderate to severe Crohn’s disease, plaque psoriasis, and active ulcerative colitis. Credits: Tada Images/Shutterstock.com South Korea-based Dong-A ST has received a US Food and Drug Administration (FDA) approval for Imuldosa (ustekinumab-srlf/DMB-3115), a biosimilar that references Johnson & Johnson ’s (J&J) blockbuster therapy Stelara (ustekinumab). As per an 11 October press announcement, the company will launch Imuldosa in the US. However, it did not specify the product’s launch date. While Stelara’s composition of matter patent expired in September 2023, none of the approved biosimilars have been launched yet, and Imuldosa will face an increasingly crowded biosimilar market when it can be made available. The list of already approved biosimilars includes Amgen ’s interchangeable biosimilar Wezlana (ustekinumab-auub), which became the first approved Stelara biosimilar when it gained FDA approval in November 2023. However, Amgen’s copycat therapy will not enter the market until 1 January 2025 after settling a patent lawsuit with J&J. Similarly, Samsung Bioepis’s Pyzchiva (ustekinumab-ttwe), another interchangeable biosimilar, which gained approval in July 2024, will not gain its “interchangeable” designation until the exclusivity period for Wezlana ends, and will be launched in February 2025. Additional approved biosimilars include Alvotech and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn) and Fresenius Kabi and Formycon’s Otulfi (ustekinumab-aauz). The latter became the fourth approved biosimilar earlier this month and is expected to launch on the market a month after Wezlana. See Also: Activist investor Starboard cries foul play in exec U-turn at Pfizer Activist investor Starboard forges $1bn stake in Pfizer to swing profits In accordance with the 2023 patent expiry, which tends to weaken sales of a brand name product, GlobalData’s consensus forecasts project a steady drop in the total sales of Stelara starting in 2024. While Stelara generated $10.9bn in sales in 2023 in a market without any biosimilars, the forecast predicts Stelara’s revenue to slip to $10bn in 2024, $7.1bn in 2025, and $5.2bn in 2026. GlobalData is the parent company of Pharmaceutical Technology. Stelara is a human IgG1 kappa monoclonal antibody designed to bind with high affinity and specificity to the IL-12 subunit beta used by the interleukin (IL)-12 and IL-23 cytokines, which are implicated to play a role in inflammation. Stelara is indicated for use in patients with active psoriatic arthritis as well as moderate to severe Crohn’s disease, plaque psoriasis, and active ulcerative colitis. Other Stelara biosimilars in development include Accord BioPharma’s DMB-3115, Celltrion ’s CT-P43, and Biocon ’s BMAB-1200. Earlier in February 2024, Rani Therapeutics announced positive topline data from its Phase I study (NCT05890118) of RT-111, a non-injectable Stelara biosimilar version that contains CT-P43.

临床1期上市批准突破性疗法临床结果

2024-08-29

·PMLiVE

EC approves Celltrion’s Stelara biosimilar SteQeyma for inflammatory diseases

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.

临床3期上市批准临床结果免疫疗法生物类似药

2024-08-26

·PipelineReview

European Commission approves Celltrion’s SteQeyma® (CT-P43), a biosimilar to Stelara® (ustekinumab), for the treatment of multiple chronic inflammatory diseases

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.libproxy1.nus.edu.sg/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

上市批准临床结果临床3期免疫疗法生物类似药

100 项与乌司奴单抗生物类似药 (Celltrion) 相关的药物交易

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研发状态

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适应症	国家/地区	公司	日期
活动性中度溃疡性结肠炎	澳大利亚	Celltrion Healthcare Australia Pty Ltd.	2024-09-11
活动性重度溃疡性结肠炎	澳大利亚	Celltrion Healthcare Australia Pty Ltd.	2024-09-11
活动性中度克罗恩病	加拿大	Celltrion, Inc.	2024-08-01
活动性重度克罗恩病	加拿大	Celltrion, Inc.	2024-08-01
银屑病关节炎	韩国	Celltrion, Inc.	2024-06-12
溃疡性结肠炎	韩国	Celltrion, Inc.	2024-06-12
克罗恩病	韩国	Celltrion, Inc.	2024-06-12
斑块状银屑病	韩国	Celltrion, Inc.	2024-06-12

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04673786 (Pubmed \| BioDrugs) 人工标引	临床3期	斑块状银屑病	509	CT-P43	積淵餘廠積築膚憲簾鑰(網廠糧構遞選餘淵鹽簾) = 觸積網選遞糧鹹夢繭鹹壓憲繭簾鑰積廠獵積餘 (膚憲齋襯夢積顧衊築簾 ) 更多	相似	2024-01-01
				Originator Ustekinumab	積淵餘廠積築膚憲簾鑰(網廠糧構遞選餘淵鹽簾) = 艱觸衊構窪窪鬱鬱艱淵壓憲繭簾鑰積廠獵積餘 (膚憲齋襯夢積顧衊築簾 ) 更多
NCT04673786 (Phase 3 Study \| CT-P43, CTgov)	临床3期	斑块状银屑病	509	CT-P43	壓淵糧衊積壓鑰獵鹽觸(餘蓋鹹醖簾獵蓋膚簾窪) = 糧積鏇窪憲淵鏇願憲顧艱夢鑰獵鬱網淵夢壓膚 (鹹遞選範製鑰齋淵廠構, 鑰範積築範蓋鏇襯齋鑰 ~ 鹹衊製鹹簾壓鏇膚獵範) 更多	-	2023-06-05
NCT04673786 (Phase 3 Study, EADV2022)	临床3期	斑块状银屑病	509	CT-P43 45 mg	艱廠鑰範積蓋簾鑰齋夢(繭願顧窪獵壓蓋夢積襯) = no hypersensitivity or malignancy were reported up to Week 28 衊獵鬱願鏇醖鬱憲網憲 (鏇鹹遞鹹淵憲蓋窪鏇繭 ) 更多	积极	2022-09-07
				UST 45 mg