Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activity to Adalimumab on First Line With Therapeutic Drug Concentration: A Randomized, Multicentre, Controlled Trial

A substantial fraction of IBD patients with an initial response to infliximab or adalimumab later experience re-emerging active disease despite ongoing anti-Tumour Necrosis Factor (TNF) agents maintenance therapy. The optimal intervention in patients with secondary loss-of-response (LOR) is still poorly defined, as there are still scant data on how best to choose the next intervention from among dose-intensification, switch to another anti-TNF or switch out of the anti-TNF class. Moreover, according to STRIDE 2 recommendations and CALM study, optimize patients based solely on lack of biological remission (CRP, calprotectin) can be discuss. If CALM study has showed that the intervention arm based on regular monitoring fecal calprotectin, CRP and/or CDAI to optimize patients under adalimumab was significantly associated to an increase rate of mucosal healing that the standard of care strategy based on only clinical activity, TDM was not available to guide drug optimization strategy.

开始日期2024-10-01

申办/合作机构

Centre Hospitalier Universitaire de Saint-Etienne

[+1]

NCT02722044 / Completed临床3期

An Open-label Single-arm Multicenter Study to Evaluate Usability of a Subcutaneous (SC) Autoinjector (AI) for a Proposed Adalimumab Biosimilar (M923) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)

The purpose of this study is to evaluate the usability of an auto-injector (AI) for the delivery of M923 in patients with rheumatoid arthritis (RA)

开始日期2016-04-01

申办/合作机构

Momenta Pharmaceuticals, Inc.

NCT02675023 / Completed临床1期

A Randomized, Open-label, Two-arm, Parallel Group, Single Dose Study to Assess the Pharmacokinetics and Safety of M923 Administered Via Auto-injector or Prefilled Syringe, in Healthy Subjects

This study will assess the pharmacokinetic (PK) and safety of a single 0.8 mL (40 mg) subcutaneous (SC) dose of M923 administered via an auto-injector (AI) or a prefilled syringe (PFS) in healthy subjects.

开始日期2016-01-01

申办/合作机构

Momenta Pharmaceuticals, Inc.

100 项与阿达木单抗生物类似药(Momenta Pharmaceuticals, Inc.) 相关的临床结果

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100 项与阿达木单抗生物类似药(Momenta Pharmaceuticals, Inc.) 相关的转化医学

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100 项与阿达木单抗生物类似药(Momenta Pharmaceuticals, Inc.) 相关的专利（医药）

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项与阿达木单抗生物类似药(Momenta Pharmaceuticals, Inc.) 相关的文献（医药）

2023-01-01·Frontiers in pharmacology

Efficacy and safety of adalimumab biosimilar (HS016) in inflammatory bowel disease from the real-world study.

Article

作者: Zhou, He ; Liang, Jie ; Wang, Fang ; Li, Xiaofei ; Yang, Gang ; Shi, Yanting ; Li, Ruixia ; Wu, Tong

Objective: Adalimumab (ADA) is an effective treatment for inflammatory bowel disease (IBD), both ulcerative colitis (UC) and Crohn's disease (CD). The equal effect between the original ADA and biosimilars from Europe and the United States has been shown. However, the biosimilar of ADA is different in China. The effectiveness and safety data of ADA biosimilar (HS016) in China have yet to be discovered. Patients and methods: 91 patients (75 CD, 16 UC) received HS016 treatment and were enrolled in this study. Therapeutic response and safety profiles were analyzed. Therapeutic drug monitoring (TDM) was also carried out among nonresponse patients. After being considered as "nonresponse" (after three or 6 months of treatment), 20 patients' serum TNFα concentrations were measured and correlated to their disease severity. Results: Among active CD patients (n = 61), 75.4% (46/61) at 12 w, 73.8% (45/61) at 26 w, 50.8% (31/61) at 52 w achieved the clinical response, respectively; 55.7% (34/61) at 12 w, 65.6% (40/61) at 26 w, and 45.9% (28/61) at 52 w achieved clinical remission. The maintained remission rates of CD (n = 14) in clinical remission were 100% (14/14) at 12 w, 78.6% (11/14) at 26 w, and 63.6% (7/11) at 52 w, respectively. Among active UC patients, 37.5% (6/16) at 12 w and 50% (8/16) at 26 w achieved clinical response. Total adverse event rates were 5.5% (5/91) during 52-week visits. Due to the inadequate serum drug concentration, 30.4% (7/23) of patients had poor clinical responses. Elevations of serum anti-drug antibodies occurred in one additional patient (4.3%). Conclusion: ADA biosimilar HS016 had good efficacy and safety in Chinese IBD patients.

2020-06-01·BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

Comparison of the Efficacy and Safety of Adalimumab (Humira) and the Adalimumab Biosimilar Candidate (HS016) in Chinese Patients with Active Ankylosing Spondylitis: A Multicenter, Randomized, Double-Blind, Parallel, Phase III Clinical Trial

Article

作者: Li, Jingyang ; Jiang, Lindi ; Li, Fen ; Wu, Huaxiang ; Wei, Wei ; Li, Tianwang ; Dong, Lingli ; Li, Mengtao ; He, Lan ; Zeng, Xiaofeng ; Zuo, Xiaoxia ; Wan, Weiguo ; Xu, Jian ; Liu, Huaxiang ; He, Dongyi ; Su, Jinmei ; Liu, Xiangyuan ; Wang, Yanyan ; Chen, Haiying ; Xu, Jianhua ; Lu, Xin ; Liu, Yi ; Li, Xiaofeng ; Zhao, Dongbao ; Tao, Yi ; Zhang, Zhiyi ; Huang, Anbin ; Huang, Cibo ; Zhang, Zhuoli ; Liu, Xiumei

OBJECTIVE:

The aim of this study was to evaluate the efficacy and safety of the biosimilar candidate of adalimumab (HS016) compared with adalimumab (Humira) for the treatment of active ankylosing spondylitis.

METHODS:

A multicenter, randomized, double-blind, parallel, positive control, phase III clinical trial was conducted at 28 locations in China. Patients with active ankylosing spondylitis were randomized in a 2:1 ratio to subcutaneously receive 40 mg of either HS016 or adalimumab every other week for 24 weeks. The primary endpoint was to achieve at least a 20% improvement (ASAS20) in patients at 24 weeks according to the Assessment of Spondyloarthritis International Society criteria. The secondary endpoint included other efficacy assessment parameters, health evaluations, safety, pharmacokinetic, and immunogenicity parameters.

RESULTS:

Following the random assignment of 648 patients into HS016 (n = 416) and adalimumab (n = 232) groups, no significant difference was found in the ASAS20 response rates at 24 weeks between the HS016 (364/416, 87.5%) and adalimumab (209/232, 90.1%) treatments and the difference between the response rates (- 2.59%; 90% confidence interval [CI] - 6.77 to 1.60) was within the predefined equivalence margin (± 15%). There were also no significant differences when the secondary endpoints were compared (all p > 0.05). Similarly, the rates of treatment-emergent adverse events (TEAEs) were not significantly different between the two groups, with most TEAEs being mild to moderate. Only nine severe cases were found, including seven within the HS016 group, three (0.7%) of which were tuberculosis cases. Plasma concentrations of HS016 and adalimumab from weeks 12 to 14 were similar during the steady-state period and steady-state maximal concentration (C_max,ss) was equivalent for HS016 (7356.6 ng/mL) and adalimumab (7600.3 ng/mL). The accumulated proportion of patients with positive human anti-human antibodies (HAHAs) at week 24 was 326/412 (79.1%) in the HS016 group and 183/229 (79.9%) in the adalimumab group (p > 0.05), while the accumulated proportion of patients with positive neutralizing antibody (NAb) tests were 72/412 (17.5%) in the HS016 group and 43/229 (18.8%) in the adalimumab group (p > 0.05).

CONCLUSION:

HS016 resembled adalimumab in efficacy and safety over the 24-week treatment period.

TRIAL REGISTRATION NUMBER:

ChiCTR1900022520.

2018-02-01·Pharmacology research & perspectives4区 · 医学

Pharmacokinetic equivalence, comparable safety, and immunogenicity of an adalimumab biosimilar product (M923) to Humira in healthy subjects

4区 · 医学

ArticleOA

作者: Darne, Siddhesh ; Weilert, Doris ; Rosano, Molly ; Pavlova, Borislava G. ; Doralt, Jennifer ; Hillson, Jan ; Goel, Niti ; Caminis, John ; Chance, Kamali ; Reeve, Russell ; Alai‐Safar, Mehrshid ; Roach, James ; Huntenburg, Carolyn ; Mant, Tim ; Rhyne, Paul W. ; Ganguly, Tanmoy ; Palmer, Donna

Abstract:

The aims of this randomized, double‐blind, three‐arm, single‐dose study were to demonstrate pharmacokinetic (PK) equivalence of the adalimumab biosimilar M923 (hereafter referred to as “M923”) to each of 2 reference products, and to assess M923's safety and immunogenicity. Primary PK endpoints were maximum observed concentration (Cmax), area under the curve (AUC) from time 0 extrapolated to infinity (AUC0‐inf), and AUC from time 0 to 336 hours (AUC0‐336). Secondary endpoints included safety and immunogenicity assessments. Healthy subjects were randomized 1:1:1 to receive a 40‐mg dose of M923 (n = 107); adalimumab US Humira (n = 105), hereafter referred to as “US Humira”; or adalimumab EU Humira (n = 103), hereafter referred to as “EU Humira.” PK equivalence was demonstrated for all primary PK endpoints. Geometric least squares means ratios (GMRs) for Cmax, AUC0‐inf, and AUC0‐336 were 99.4, 100.9, and 100.5, respectively, between the M923 and EU Humira arms and 102.6, 104.2, and 102.9 between the M923 and US Humira arms. The 90% confidence intervals of the GMRs for all PK endpoints were within prespecified confidence bounds of 80%‐125%. Adverse event rates were similar across the M923 (47.7%), US Humira (50.9%), and EU Humira (53.3%) arms and were generally mild (73.7%) or moderate (22.0%). The proportion of subjects with a confirmed antidrug antibody (ADA) response was similar across study arms. This study demonstrated bioequivalent PK among M923, US Humira, and EU Humira and demonstrated that the PK parameters were consistent with similar safety and tolerability profile and ADA response rates.

项与阿达木单抗生物类似药(Momenta Pharmaceuticals, Inc.) 相关的新闻（医药）

2023-10-11

·GlobeNewswire-Health Care

Samsung Bioepis Presents Two Abstracts at EADV 2023 Congress, Highlighting Continuous Dedication in Dermatology

Phase 3 study for SB17, Samsung Bioepis’ ustekinumab biosimilar candidate, demonstrates biosimilarity with reference ustekinumab through equivalent efficacy and comparable safety and pharmacokinetics (PK) up to Week 28Also presents 4-year follow-up data of efficacy and safety of adalimumab biosimilar SB5 in patients with moderate to severe psoriasis from British Association of Dermatologics and Immunomodulators Register (BADBIR) INCHEON, South Korea, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd.’s new data on its ustekinumab biosimilar candidate SB17 and four-year follow-up data for its adalimumab biosimilar SB5 are presented today at the European Academy of Dermatology and Venereology (EADV) Congress being held from October 11 to 14 in Berlin, Germany. The Phase 3 study for SB17, a proposed biosimilar to Stelara1 (ustekinumab), was a randomized double-blind study to compare efficacy, safety, pharmacokinetics (PK), and immunogenicity of SB17 with reference ustekinumab (UST) in patients with moderate to severe plaque psoriasis. The study demonstrated biosimilarity of SB17 to UST through equivalent efficacy and comparable safety and PK up to Week 28. The study met the primary endpoint - percent change from baseline in Psoriasis Area Severity Index (PASI) at Week 12, with an adjusted difference of -0.6 (95% confidence interval (CI): [−3.780 to 2.579], per-protocol set), being fully contained within the pre-defined equivalence margin. Other efficacy and safety endpoints were comparable up to Week 28. SB17 is Samsung Bioepis’ fourth candidate in immunology pipeline, following SB4 (etanercept), SB2 (infliximab) and SB5 (adalimumab). In September, the company announced a partnership deal with Sandoz to commercialize SB17 in the United States (US), Canada, European Economic Area (EEA), Switzerland and United Kingdom (UK). Samsung Bioepis also shared 4-year follow-up data of effectiveness and safety of its adalimumab biosimilar SB5 in patients with moderate to severe psoriasis from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) - a UK and Ireland registry that assesses the long-term safety of biologic treatments for psoriasis, in which Samsung Bioepis has participated since May 2016. The 4-year follow-up data of eligible patients treated with SB5 between June 2019 and August 2022 from BADBIR indicated that SB5 can be started or transitioned from reference adalimumab in patients with moderate-to-severe psoriasis with an effectiveness and safety profile. “Presenting two abstracts at EADV demonstrates our continuous commitment to providing clinically proven biosimilars in terms of efficacy, safety and immunogenicity to patients who need them and making physicians and patients confident on use of biosimilar in real setting,” said Hyejin Kim, Vice President and Medical and Lifecycle Safety Team Leader at Samsung Bioepis. SB5 was approved by the European Commission (EC) in August 2017, under the brand name IMRALDI™ as a biosimilar to HUMIRA2. In Europe, IMRALDI™ is commercialized by Biogen along with BENEPALI™ (etanercept; SB4) and FLIXABI™ (infliximab; SB2). Samsung Bioepis’ and Biogen’s anti-TNF treatment products have helped nearly 256,0003 patients in Europe. Details of the Samsung Bioepis’ abstracts are as follows: Abstract TitleAbstract DetailsA Randomised, Double-blind, Phase III Study Demonstrating Clinical Similarity of SB17 (Proposed Ustekinumab Biosimilar) to Reference Ustekinumab in Patients with Moderate to Severe Plaque PsoriasisAbstract ID: 1320Poster ID: P0720Poster Open Date/Time: Oct 11, 9:00 AMAuthors: Steven Feldman, Joanna Narbutt, Giampiero Girolomoni, Jan Brzezicki, Nataliya Reznichenko, Maria Agnieszka Zegadlo-Mylik, Grazyna Pulka, Magdalena Dmowska-Stecewicz, Elżbieta Kłujszo, Dmytro Rekalov, Lidia Rajzer, Jiyoon Lee, Minkyung Lee, and Young Hee RhoLong-Term Real-World Data of SB5 (Adalimumab Biosimilar) Treatment in Patients with Moderate-to-Severe Psoriasis from the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR))Abstract ID: 4782 Poster ID: P2569 Poster Open Date/Time: Oct 11, 9:00 AMAuthors: Giampiero Girolomoni, Steven Feldman, Alexander Egeberg, Luis Puig Sanz, Hojung Jung, Younjin Park, Younju Lee About Samsung Bioepis Co., Ltd.Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, endocrinology and gastroenterology. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn. References:___________________ 1 Stelara is a trademark of Janssen Pharmaceuticals. 2 Humira is a trademark of AbbVie Biotechnology Ltd. 3 2022 Q3 Biogen Earnings presentation.

临床3期临床结果上市批准引进/卖出

2023-02-20

·信达生物

临床试验 | 信达生物IBI375治疗一线胆管癌临床研究进行中

胆管癌人体的胆囊是用来贮存和排泄胆汁，并参与食物消化的器官。胆管是用来输送胆汁的管道，是连接肝脏，胆囊和小肠的导管网络。而胆管癌就是一种起源于胆管上皮细胞的恶性肿瘤。胆管癌发病率很低，但其恶性程度高，导致人体的病变十分严重。按所发生的部位可分为肝内和肝外胆管癌两大类。近年来胆管癌的发病率逐年升高，手术是唯一具有治愈潜力的治疗方式，但是仅有少数早期患者在诊断时具有手术机会。肿瘤被根治性切除的胆管癌患者复发率仍较高，不能手术切除或晚期胆管癌患者在目前已有的系统治疗中，疗效较差，标准治疗（顺铂联合吉西他滨）的患者总生存期小于1年。信达生物制药（苏州）有限公司正在开展一项“评价Pemigatinib对比吉西他滨联合顺铂一线治疗携带FGFR2重排的、手术不可切除或转移性胆管癌患者疗效和安全性的随机、开放、阳性药物对照、多中心III期临床研究”。这项研究已经得到了国家药品监督管理局的批准（批件号为：JXHL1900229/ JXHL1900230/JXHL1900231）和医院伦理委员会的批准，计划全国招募65名一线胆管癌患者。试验药物简介 Pemigatinib是FGFR1、FGFR2和FGFR3的强效选择性抑制剂。该化合物拟定用于伴FGFR2重排的不可手术切除和/或转移性胆管癌受试者的一线治疗。主要入组标准如果您符合以下条件并有意向参加该研究，请及时与我们联系。a)能够理解并且愿意签署研究的书面ICF。b)签署ICF时≥18岁的男性或女性受试者。c)经组织学或细胞学证实为胆管癌，既往未接受过治疗，且视为不可手术切除/复发/转移（按照AJCC癌症分期手册[AJCC 2010]为IV期）。d)经CT或MRI评估且根据RECIST v1.1标准确定为放射性可测量或可评价疾病（Eisenhauer et al 2016）。e)ECOG体能状态为0~1。f)有FGFR2重排记录。研究中心清单研究中心名称主要研究者联系方式复旦大学附属中山医院周俭文老师15185702784天津医科大上海交通大学医学院附属新华医院学眼科医院龚伟苏老师15821775631华中科技大学同济医学院附属同济医院张必翔肖老师18271854339广西医科大学第一附属医院彭涛邓老师15240671989安徽省立医院刘连新朱老师18792183002四川大学华西医院文天夫陈老师13881450367天津市肿瘤医院宋天强李老师13502011867昆明市第一人民医院冉江华车老师13759569943苏北省人民医院柏斗胜宋老师13775728511中山大学附属第一医院匡铭王老师13907784007中山大学孙逸仙纪念医院陈亚进陈老师18826411231浙江大学医学院第二附属医院严盛梅老师13575830265哈尔滨医科大学附属肿瘤医院张玉宝黄老师15558042610湖北省肿瘤医院包乐群欧阳老师18202773112四川省肿瘤医院冯燮林徐老师13890149031北京协和医院赵海涛卢老师15797870630江苏省人民医院李相成李老师15951897893青岛大学附属医院于洪升李老师17854232164福建省肿瘤医院刘景丰陈老师13609532187树兰（杭州）医院张武严老师17320161152关于信达生物- 滑动查看更多介绍 -“始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的理想和目标。信达生物成立于2011年，致力于开发、生产和销售肿瘤、代谢、自身免疫、眼科等重大疾病领域的创新药物。2018年10月31日，信达生物制药在香港联合交易所有限公司主板上市，股票代码：01801。自成立以来，公司凭借创新成果和国际化的运营模式在众多生物制药公司中脱颖而出。建立起了一条包括36个新药品种的产品链，覆盖肿瘤、自身免疫、代谢、眼科等多个疾病领域，其中7个品种入选国家“重大新药创制”专项。公司已有8个产品（信迪利单抗注射液，商品名：达伯舒®，英文商标：TYVYT®；贝伐珠单抗生物类似药，商品名：达攸同®，英文商标：BYVASDA ®；阿达木单抗生物类似药，商品名：苏立信®，英文商标：SULINNO ®；利妥昔单抗生物类似药，商品名：达伯华®，英文商标：HALPRYZA®；佩米替尼片，商品名：达伯坦®，英文商标：PEMAZYRE®；奥雷巴替尼片，商品名：耐立克®；雷莫西尤单抗，商品名：希冉择®，英文商标：CYRAMZA®；塞普替尼，商品名：睿妥®，英文商标：Retsevmo®）获得批准上市，3个品种在NMPA审评中，6个新药分子进入III期或关键性临床研究，另外还有19个新药品种已进入临床研究。信达生物已组建了一支具有国际先进水平的高端生物药开发、产业化人才团队，包括众多海归专家，并与美国礼来制药、赛诺菲、Adimab、Incyte、MD Anderson 癌症中心等国际合作方达成战略合作。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。详情请访问公司网站：www.innoventbio.com或公司领英账号：Innovent Biologics。

临床3期

2023-02-16

·药时代

“药王”Humira遭生物类似药冲击，看艾伯维下一步棋着何处

作为全球最畅销的非新冠类药物，过去二十年Humira为艾伯维带来了超过2000亿美元的收入。2022年，Humira全年销售额达212.37亿美元，同比增长2.6%，再次蝉联“药王”宝座。然而，从2018年Humira失去欧洲专利保护起，多款生物仿制药陆续登陆市场，逐渐侵占欧洲市场份额。2023年，Humira再次失去美国专利保护，艾伯维恐面临制药行业有史以来最大的“专利悬崖”。如此激烈竞争下，“药王”Humira垄断时代是否走到尽头？01首款Humira生物类似药在美上市1月31日，安进宣布其推出的首个Humira生物类似药Amjevita已正式进入美国市场，同时这也是FDA批准的首款阿达木单抗生物类似药。安进公司表示，Amjevita在降低成本同时，其疗效与原研药相当。目前，Amjevita根据医保政策，以两项不同优惠政策提供：一种是比Humira的标价低，但是会提供大量的回扣和折扣给药房福利管理者（PBMs），这样可以降低净成本，增加Amjevita在保险计划中的覆盖率和偏好度。另一种是比Humira的标价低55%，但是不提供回扣和折扣，这样可以吸引那些没有保险或者自付费用较高的消费者，也可以给医院和诊所提供更便宜的选择。生物类似药的出现宣告了艾伯维对Humira的垄断结束。不过，更激烈的角逐将于今年7月开启。届时，来自三星、勃林格殷格翰、诺华和辉瑞等公司开发的Humira生物类似药将陆续在美国上市，与全球最畅销的药物展开竞争。02艾伯维：迎接Humira 2.0到来为了给专利悬崖这个天坑“找平”，艾伯维公司从去年开始将目光投向潜在“继任者”——口服JAK抑制剂Rinvoq和新型抗炎药IL-23抑制剂Skyrizi。据报道，2021年艾伯维已将部分资金从营销Humira转向这些“兄弟”药物。艾伯维首席执行官Rick Gonzalez表示，Skyrizi和Rinvoq将在Humira所有适应症基础上增加银屑病关节炎、特应性皮炎等多个新适应症，以实现向Humira 2.0转化。同时他还强调，未来Skyrizi和Rinvoq合并峰值销售额将超过Humira峰值收入。自商业化以来，“继任者”不负艾伯维所望。2022年，两者整体收入迅速飙升，上半年同比增长分别达到75.7%和55.1%。Skyrizi和Rinvoq正在加速实现对Humira主要适应症的覆盖和超越。艾伯维公司对Humira 2.0持乐观态度，并预计2025年Skyrizi和Rinvoq组合销售额将达到150亿美元，或有望弥补Humira遭遇生物类似药围剿所造成的损失。03艾伯维下一步行动面临专利到期，艾伯维没有坐以待毙。艾伯维计划将未来研发预算提高一倍以上，同时表示公司完全有能力抵抗Humira“专利悬崖”带来的负面影响。虽然2023年Humira的销售额可能下降37%，但预计2025年艾伯维可重新恢复强劲的销售增长。2月9日，Rick Gonzalez再次重申新一代免疫学药物Skyrizi和Rinvoq将作为Humira 2.0持续创新发展，未来会不断扩大药物使用范围，以涵盖多种炎症性疾病。除此之外，为减少对Humira的依赖，艾伯维取消在2019年以630亿美元巨额收购艾尔建公司后对交易设置的20亿美元上限。Rick Gonzalez表示：“目前，该公司处在关键机遇期，正等待合适的时机来扩大交易。”此前，FDA已批准该公司生产Restasis类似药，用于干眼症治疗。如今，巨大危机对于艾伯维来说同时也是具有颠覆性意义的挑战。当前，艾伯维寄希望于两款新型免疫学药物Skyrizi和Rinvoq来填补Humira的收入下降，然而要想赶上过去几年里Humira高销售数额，仍有很长的路需要走。仿制药/生物类似药的出现，或许会挤压原研药的生存空间，但也可以倒逼企业创新，推动药企的发展，不再混吃等死，坐吃山空。“药王”桂冠终将易主，创新精神永不止步。参考资料：1.https://endpts.com/the-top-100-venture-investors-in-biopharma-today-whos-staying-at-the-deals-table/2.https://endpts.com/the-top-100-venture-investors-in-biopharma-today-whos-staying-at-the-deals-table/3.https://endpts.com/abbvie-talks-next-steps-as-first-humira-competitor-makes-it-to-market/4.其它互联网公开资料撰稿：Cathy封面图来源：123rf推荐阅读CDK4/6抑制剂曲拉西利3期临床结果出炉：主要终点达标，ORR却比安慰剂低11%，令人震惊…2天3起创新药出海：春天来了，万物复苏，又到了药企们交易的季节阿尔茨海默病、癌症......看「新型自噬降解剂」的研究进展，这是继PROTAC之后又一新起之秀点击这里，报名创新药BD高阶研讨会【上海站】！

生物类似药专利到期

100 项与阿达木单抗生物类似药(Momenta Pharmaceuticals, Inc.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB04	DB00051

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
类风湿关节炎	临床3期	美国	Momenta Pharmaceuticals, Inc.	2016-04-01
斑块状银屑病	临床3期	美国	Momenta Pharmaceuticals, Inc.	2015-09-01
斑块状银屑病	临床3期	保加利亚	Momenta Pharmaceuticals, Inc.	2015-09-01
斑块状银屑病	临床3期	加拿大	Momenta Pharmaceuticals, Inc.	2015-09-01
斑块状银屑病	临床3期	捷克	Momenta Pharmaceuticals, Inc.	2015-09-01
斑块状银屑病	临床3期	爱沙尼亚	Momenta Pharmaceuticals, Inc.	2015-09-01
斑块状银屑病	临床3期	德国	Momenta Pharmaceuticals, Inc.	2015-09-01
斑块状银屑病	临床3期	拉脱维亚	Momenta Pharmaceuticals, Inc.	2015-09-01
斑块状银屑病	临床3期	波兰	Momenta Pharmaceuticals, Inc.	2015-09-01
斑块状银屑病	临床3期	斯洛伐克	Momenta Pharmaceuticals, Inc.	2015-09-01

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临床结果

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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


NCT02722044 (CTgov)	临床3期	类风湿关节炎	33	M923	襯糧襯範廠觸遞壓餘糧(遞糧憲築鑰製艱鑰醖觸) = 憲築壓壓夢願築廠膚襯選選繭遞餘範網糧襯襯 (齋鹽夢廠簾選艱構積顧, 築蓋顧鏇夢艱糧觸襯廠 ~ 夢窪鏇築鏇網簾鬱壓獵) 更多	-	2018-05-01