A Randomized, Active-Controlled, Double-Masked, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema

This is a Randomized, Active-Controlled, Double-Masked, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P42 in comparison with Eylea in Patients with Diabetic Macular Edema

开始日期2021-07-22

申办/合作机构

Celltrion, Inc.

EUCTR2020-004278-23-HU / Unknown status临床3期

A Randomized, Active-Controlled, Double-Masked, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P42 in Comparison with Eylea in Patients with Diabetic Macular Edema

开始日期2021-02-08

申办/合作机构

Celltrion, Inc.

100 项与阿柏西普生物类似药(Celltrion) 相关的临床结果

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100 项与阿柏西普生物类似药(Celltrion) 相关的专利（医药）

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项与阿柏西普生物类似药(Celltrion) 相关的文献（医药）

2024-06-01·Ophthalmology Retina

Biosimilar Candidate CT-P42 in Diabetic Macular Edema

Article

作者: Romanczak, Dominika ; Bae, Youngmin ; Papp, Andras ; Janco, Ladislav ; Lee, Sangmi ; Chauhan, Rohan ; Sagong, Min ; Ahn, Keumyoung ; Wolf, Sebastian ; Mange, Shobhana ; Kim, Sunghyun ; Veith, Miroslav ; Eremina, Alena ; Brown, David M ; Romanowska-Dixon, Bożena ; Kang, Hyejin ; Stanga, Paulo-Eduardo ; Kanta Mondal, Lakshmi ; Dusova, Jaroslava ; Kim, Suyoung ; Zavgorodnya, Nataliya ; Veselovsky, Milan

OBJECTIVETo demonstrate the therapeutic similarity of CT-P42 compared with reference aflibercept (Eylea) in adult patients with diabetic macular edema (DME).DESIGNRandomized, active-controlled, double-masked, phase III clinical trial PARTICIPANTS: Patients with a diagnosis of either type 1 or 2 diabetes mellitus with DME involving the center of the macula.METHODSPatients were randomized (1:1) to receive either CT-P42 or reference aflibercept (2 mg/0.05 ml) by intravitreal injection every 4 weeks (5 doses), then every 8 weeks (4 doses), in the main study period. Results up to week 24 are reported herein.MAIN OUTCOME MEASURESThe primary end point was mean change from baseline at week 8 in best-corrected visual acuity (BCVA) using the ETDRS chart. Equivalence between CT-P42 and reference aflibercept was to be concluded if the 2-sided 95% confidence interval (CI) (global assumptions) and 2-sided 90% CI (United States Food and Drug Administration [FDA] assumptions) for the treatment difference fell entirely within the equivalence margin of ±3 letters, as assessed in the full analysis set.RESULTSOverall, 348 patients were randomized (CT-P42: 173; reference aflibercept: 175). Best-corrected visual acuity improved from baseline to week 8 in both groups, with a least squares mean (standard error) improvement of 9.43 (0.798) and 8.85 (0.775) letters in the CT-P42 and reference aflibercept groups, respectively. The estimated between-group treatment difference was 0.58 letters, with the CIs within the predefined equivalence margin of ±3 letters (95% CI, -0.73 to 1.88 [global]; 90% CI, -0.52 to 1.67 [FDA]). Through week 24, other efficacy results for the 2 groups, in terms of change in BCVA and retinal central subfield thickness, as well as ETDRS Diabetic Retinopathy Severity Scale score, supported therapeutic similarity. Pharmacokinetics, usability, safety (including the proportions of patients experiencing ≥1 treatment-emergent adverse event [CT-P42: 50.3%; reference aflibercept: 53.7%]), and immunogenicity were also comparable between groups.CONCLUSIONSThis study in patients with DME demonstrated equivalence between CT-P42 and reference aflibercept (2 mg/0.05 ml) in terms of efficacy, with similar pharmacokinetic, usability, safety, and immunogenicity profiles.FINANCIAL DISCLOSURE(S)Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

项与阿柏西普生物类似药(Celltrion) 相关的新闻（医药）

2023-12-30

·生物制药小编

抵御首款仿制药，再生元赢得了专利战

近日（2023年12月28日），再生元与Mylan持续1年多的专利战落下了帷幕。再生元获得了胜利，Mylan被判侵犯了阿柏西普一项配方专利--11084865专利的权利要求6和25，以及给药方案专利-10888601--权利要求11和19、11253572--权利要求4、7、9、11、14-17。Mylan是第一个提交阿柏西普生物仿制药aBLA（简化生物制品许可申请）的仿制药开发商。早在2021年10月，Mylan就向FDA递交了M710的上市申请，2021年12月获得了FDA的受理。2022年8月，再生元对Mylan公司发起了专利指控，称其侵犯了阿柏西普24项专利。包括：7项适应症专利--9254338、9669069、10130681、10857205、10888601、10973879、11253572 和11253572，这些专利对以特定给药方案使用阿柏西普以治疗某些血管生成性眼部疾病的方法进行了保护。3项配方专利--10464992、11066458、11084865，对阿柏西普稳定配方的制备方法进行了保护。14项制备方法专利--7070959、9222106、9816110、10406226、10415055、10669594、10927342、11053280、11104715、11174283、11186625、11299532、 11306135和11332771。这也是再生元首次对阿柏西普生物仿制药开发商提起BPCIA（生物制品价格竞争与创新法案）诉讼。根据再生元权利主张，其要求法院判决Mylan专利侵权，并要求Mylan赔偿金钱损失以及初步和永久禁令等在内的和解补偿。虽然与Mylan的专利战中取得了胜利，但是再生元还要应对其他虎视眈眈的仿制药厂商。2023年6月29日和30日，Formycon和Celltrion两家公司分别向FDA递交了CT-P42和FYB203的上市申请，为第二家和第三家提交阿柏西普生物仿制药的仿制药厂商。2023 年11月8日，再生元对Celltrion也发起了专利侵权诉讼，指控Celltrion侵犯了38项专利。这是继Mylan之后，再生元提出的第二起涉及阿柏西普生物仿制药的BPCIA诉讼。2023年11月22日，再生元对三星Bioepis也发起了专利侵权诉讼，指控其侵犯了37项专利。阿柏西普在中国的首款仿制药已经率先到来。2022年4月26日，齐鲁制药提交了阿柏西普生物类似药（卓初明）的上市申请。2023年12月18日，卓初明获得NMPA批准上市。总结阿柏西普称霸眼科领域多年，取得远超于雷珠单抗的销售成绩，2022年销售额逼近百亿美元。然而随着竞品的出现以及专利到期的危机，阿柏西普在眼科药物中的主导地位受到冲击，去年以来出现了接连4个季度的销售额下滑。为了延长阿柏西普的专利寿命，再生元从扩大适应症、高剂量等做出诸多努力，去年10月，阿柏西普凭借在早产儿视网膜病变(ROP)数据在获得了六个月的市场独占期，今年8月还成功推出的8mg剂量版本（EYLEA HD），一定程度上可以缓解竞品的冲击。参考出处:https://www.goodwinlaw.com/en/insights/blogs/2023/06/formycon-and-celltrion-announce-fda-submission-of-ablas-seeking-approval-to-market-aflibercept-biosihttps://www.jdsupra.com/legalnews/breaking-judgment-in-regeneron-v-mylan-6824677/https://endpts.com/regeneron-wins-eylea-patent-case-against-biosimilar-developer-mylan/再生元制药就迈兰制药的生物仿制药艾力雅®（Eylea®）提起BPCIA诉讼“悬崖”边的斗法——眼科王者阿柏西普专利战进入白热化

专利侵权专利到期生物类似药

2021-05-12

·GlobeNewswire

Diabetic Macular Edema Pipeline Sees Expansion Owing to Key

Los Angeles, USA, May 12, 2021 (GLOBE NEWSWIRE) -- Diabetic Macular Edema Pipeline Sees Expansion Owing to Key Players, Key Therapies and Research & Programmes Diabetic Macular Edema Pipeline Insight report offers deep insights into emerging Diabetic Macular Edema pipeline therapies with an analysis of 50+key players and 50+key therapies. DelveInsight’s ‘Diabetic Macular Edema (DME) Pipeline Insights’ report provides a holistic view of the DME pipeline therapies that are under development in pre-clinical as well as clinical stages of development and growth prospects across the Diabetic Macular Edema landscape. Key takeaways of the Diabetic Macular Edema Pipeline report: Got queries? Want to know more? Request for Sample @ Diabetic Macular Edema Emerging Therapies and Forecast Diabetic Macular Edema: Overview Macular edema is a condition characterized by the build-up of fluid in the macula, an area in the center of the retina. The excess build-up results in the swelling and thickening of the macula leading to distorted vision. It is referred to as Diabetic Macular Edema (DME) as it is caused by a complication of diabetes called diabetic retinopathy. For more information on emerging drugs, visit Diabetic Macular Edema Pipeline Analysis The DME pipeline report proffers a rich coverage of the therapeutics by development stage, product type, and route of administration, molecule type, and MOA type for Diabetic Macular Edema across the complete product development cycle, including all clinical and non-clinical stages. Diabetic Macular Edema Pipeline Drugs Request for Sample to know which drug is expected to outperform @ Diabetic Macular Edema Pipeline Analysis, Key Companies, and Futuristic Trends Diabetic Macular Edema Therapeutics Assessment The Diabetic Macular Edema Pipeline report proffers exhaustive insights into active pipeline assets segmented by Stage, Product Type, Route of Administration, Molecule Type, Target, and Indications of various drugs. By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets By Stage and Route of AdministrationBy Stage and Product Type Get in touch with our Business executive for Rich and Deep Market Assessment and Consulting Solutions The Diabetic Macular Edema pipeline report puts on the table business opportunities, threats, prospective collaborations, strong competitors, growth strategies, and failed as well as discontinued drugs that will help the clients to keep a track of the ongoing trials, recent happenings in the DME domain. Scope of the Report Coverage: GlobalKey Players: Kodiak Sciences, Novartis Pharmaceuticals, Adverum Biotechnologies, KalVista Pharmaceuticals, Momenta Pharmaceuticals, Roche, Regeneron Pharmaceuticals, Exonate, Opthea Limited, SciFluor Life Sciences, AsclepiX Therapeutics, RemeGen, UNITY Biotechnology, Celltrion, Bio-Thera Solutions, Ripple Therapeutics, GrayBug Vision, Oxurion, Aerie Pharmaceuticals, GlaxoSmithKline, Boehringer Ingelheim, and Apexian Pharmaceuticals among others.Key Diabetic Macular Edema Pipeline Therapies: KSI 301, LKA651, ADVM-022, KVD001, MYL-1701P, Faricimab, REGN 910-3, EXN407, OPT-302, SF0166, AXT107, Brolucizumab, RC28-E, UBX1325, CT-P42, BAT5906, IBE-814, GB-102, THR-149, AR-13503, GSK2798745, BI 1026706, and APX3330 among others. Reach out how novel therapies are transforming the DME landscape @ Diabetic Macular Edema Pipeline Table of Contents Visit to know more of what’s covered @ Diabetic Macular Edema Emerging Therapies Related Reports Chronic Pain Associated With Painful Diabetic Neuropathy MarketDelveInsight's "Chronic Pain Associated with Painful Diabetic Neuropathy - Market Insights, Epidemiology, and Market Forecast-2030" report. Diabetic Foot Ulcers MarketDelveInsight’s ‘Diabetic Foot Ulcer (DFU) - Market Insights, Epidemiology, and Market Forecast—2030’ report. Diabetic Foot MarketDelveInsight's "Diabetic Foot - Market Insights, Epidemiology, and Market Forecast-2030" report. Diabetic Eye Disease MarketDelveInsight's "Diabetic Eye Disease - Market Insights, Epidemiology, and Market Forecast-2030" report. Diabetic Ketoacidosis MarketDelveInsight's "Diabetic Ketoacidosis (DKA) - Market Insights, Epidemiology, and Market Forecast-2030" report. Diabetic Gastroparesis Market SizeDelveInsight’s ‘Diabetic Gastroparesis (DGp) - Market Insights, Epidemiology and Market Forecast-2030’ report offers a detailed analysis of therapies and key pharmaceutical companies including Allergan Evoke Pharma Inc., Theravance Biopharma, Censa Pharmaceuticals, CinDome Pharma, Takeda (Millennium Pharmaceuticals, Inc.), Bird Rock Bio, and others. Diabetic Kidney Disease MarketDelveInsight's "Diabetic Kidney Disease (DKD) - Market Insights, Epidemiology, and Market Forecast-2030" report. Related Posts Understanding The Increasing Prevalence Of Diabetes And Its ComplicationsDiabetic Peripheral Neuropathy Market Landscape Diabetic Peripheral Neuropathy Medications About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing end-to-end comprehensive solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. For more insights, visit Pharma, Healthcare, and Biotech News

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研发状态

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适应症	国家/地区	公司	日期
糖尿病性黄斑水肿	韩国	Celltrion, Inc.	2024-05-29
近视脉络膜新生血管	韩国	Celltrion, Inc.	2024-05-29
视网膜静脉阻塞相关黄斑水肿	韩国	Celltrion, Inc.	2024-05-29
湿性年龄相关性黄斑变性	韩国	Celltrion, Inc.	2024-05-29

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适应症	最高研发状态	国家/地区	公司	日期
糖尿病性黄斑水肿	临床3期	斯洛伐克	Celltrion, Inc.	2021-07-22

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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


NCT04739306 (CT-P42 3.1, EURETINA2024)	临床3期	糖尿病性黄斑水肿	348	CT-P42 2mg/0.05 mL	(鑰廠願築選選蓋鏇窪淵) = Sustained and comparable efficacy maintained through Week 52 in terms of mean change from the baseline in BCVA and central subfield thickness (CST) 構鬱遞襯獵網繭夢衊範 (壓顧餘夢鑰襯襯鑰艱壓 )	积极	2024-09-19
				Aflibercept
NCT04739306 (CT-P42 3.1, CTgov)	临床3期	糖尿病性黄斑水肿	348	CT-P42 (CT-P42)	選蓋積膚廠繭願餘範鹽(衊簾鹽壓襯淵鹽窪網衊) = 醖醖鑰衊鑰襯獵鏇簾艱蓋積襯廠繭鏇壓獵網鹽 (鏇範鹽觸願艱醖觸範遞, 膚淵網顧鹽膚獵鑰餘鏇 ~ 憲鹹餘夢膚廠餘範選願) 更多	-	2023-12-05
				Eylea (Eylea)	選蓋積膚廠繭願餘範鹽(衊簾鹽壓襯淵鹽窪網衊) = 簾遞膚鑰製壓鑰夢鑰衊蓋積襯廠繭鏇壓獵網鹽 (鏇範鹽觸願艱醖觸範遞, 簾鑰糧範構窪糧構獵蓋 ~ 繭襯獵網獵窪遞簾鏇憲) 更多