A Multicenter, International, Prospective, Non-interventional, Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting

An international, multicenter, non-interventional, prospective, post-authorization, descriptive, non-PASS, study.

开始日期2023-02-16

申办/合作机构

山德士有限公司

NCT03906136 / Completed临床3期

A Randomized, Open Label Multicenter Trial to Investigate the Efficacy of a Treat-to-target (T2T) Treatment Strategy With Secukinumab (AIN457) as a First-line Biologic Compared to a Standard-of-care (SOC) Treatment Over 36 Weeks in Patients With Active Axial Spondyloarthritis (axSpA)

This is a randomized, parallel-group, open-label, multicenter study of patients with active axSpA. The aim is to demonstrate that the efficacy of a Treat-to-Target (T2T) approach (with secukinumab as first-line biologic) is superior to a Standard-Of-Care (SOC) approach in terms of achieving strong clinical efficacy in patients with active axial Spondyloarthritis (axSpA) who are naïve to biological therapy and who have had an inadequate response to non-steroidal anti-inflammatory drugs. The study will include an 8-week Screening period, a 36-week treatment period according to previous randomization, and a safety follow-up period of 20 weeks. The primary endpoint is the percentage of patients achieving an Assessment in SpondyloArthritis international Society response 40 (ASAS40) at Week 24.

开始日期2019-06-04

申办/合作机构

Novartis Pharmaceuticals Corp.

EUCTR2015-003433-10-CZ / Not yet recruiting临床3期

GP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial

开始日期2016-06-08

申办/合作机构

Hexal AG

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100 项与阿达木单抗生物类似药(Sandoz) 相关的专利（医药）

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项与阿达木单抗生物类似药(Sandoz) 相关的文献（医药）

2024-02-20·Eye (London, England)

Effect of adalimumab on choroidal thickness and choroidal vascularity index in eyes with non-infectious uveitis using enhanced-depth imaging optical coherence tomography.

Article

作者: Cem Evereklioglu ; Elif Er Arslantas ; Hidayet Sener ; Zeynep Akkul ; Kamran Gahramanov ; Duygu Gulmez Sevim ; Osman Ahmet Polat ; Fatih Horozoglu

OBJECTIVE:

To evaluate the effect of adalimumab (ADA) on choroidal thickness (ChT) and choroidal vascularity index (CVI) in eyes with non-infectious uveitis (NIU).

METHODS:

Thirty-seven eyes with NIU including Behçet disease (BD), sarcoidosis, ankylosing spondylitis (AS), juvenile idiopathic arthritis and idiopathic arthritis, 38 eyes of non-uveitic (NU) patients including BD, AS and rheumatoid arthritis, and 40 healthy control eyes were included. ADA was used for anti-TNF-naive adult (80 mg) or paediatric (40 mg) patients with refractory NIU, then 40 mg every 2-week (20 mg in children<30 kg) with controls at weeks 1, 4, 12, and 24. Images were used to measure central, nasal, and temporal ChT, and the luminal area (LA), stromal area, and total choroidal area (TCA) were analysed using enhanced-depth imaging optical coherence tomography (EDI-OCT) by ImageJ software. The CVI was then calculated as the ratio of LA to TCA.

RESULTS:

Mean ages were similar between the groups. Mean (SE) subfoveal ChT measurements for each location were also similar (for each, p > 0.05). However, calculated CVI values in eyes with NIU (0.63 ± 0.007) were significantly (p < 0.001) lower than NU eyes (0.66 ± 0.006) and controls (0.70 ± 0.007) (p < 0.001). Moreover, CVI was significantly lower in NU eyes compared to controls (p < 0.001). There were no significant CVI changes between the consecutive visits after ADA therapy in eyes with NIU (for each, p > 0.05).

CONCLUSIONS:

Decreased CVI in NIU and NU eyes indicates that systemic inflammation affects the choroidal vasculature and perfusion both in the presence and absence of ocular involvement. Although CVI may be used as a possible novel tool in monitoring ocular involvement and progression of NIU, CVI does not seem to be a biomarker for treatment monitoring in NIU.

2024-02-10·Rheumatology (Oxford, England)

Association of the clinical components in the distal interphalangeal joint synovio-entheseal complex and subsequent response to ixekizumab or adalimumab in psoriatic arthritis.

Article

作者: Dennis McGonagle ; Arthur Kavanaugh ; Iain B McInnes ; Lars Erik Kristensen ; Joseph F Merola ; Bruce Strober ; Rebecca Bolce ; Jeffrey Lisse ; Jennifer Pustizzi ; Christophe Sapin ; Christopher Ritchlin

OBJECTIVES:

To assess the frequency of simultaneous distal interphalangeal (DIP) joint disease and adjacent nail psoriasis (finger unit) among patients with psoriatic arthritis (PsA) and compare the efficacy of the interleukin (IL)-17A antagonist ixekizumab (IXE) and the tumour necrosis factor (TNF)-α inhibitor adalimumab (ADA).

METHODS:

This post hoc analysis evaluated the simultaneous occurrence of DIP joint involvement (tenderness and/or swelling) and adjacent nail psoriasis among patients with PsA from the SPIRIT-H2H (NCT03151551) trial comparing IXE to ADA. Among patients with simultaneous DIP joint involvement and adjacent nail psoriasis in ≥ 1 digit at baseline, treatment effects were assessed through week 52 for each affected finger unit; 'finger unit' defines the connected DIP joint and adjacent nail of an individual digit.

RESULTS:

A total of 354 patients had simultaneous DIP joint involvement and adjacent nail psoriasis in ≥ 1 finger unit at baseline. Among them, 1309 (IXE = 639, ADA = 670) finger units had baseline DIP joint tenderness and/or swelling and adjacent nail psoriasis. Proportions of affected finger units achieving complete resolution were significantly higher with IXE vs ADA as early as week 12 (38.8% vs 28.4%, p< 0.0001) and at all post-baseline assessments through week 52 (64.9% vs 57.5%, p= 0.0055).

CONCLUSIONS:

In this study cohort, patients with DIP joint involvement almost always had adjacent nail psoriasis. Greater resolution of DIP joint tenderness, swelling, and adjacent nail psoriasis was achieved at all timepoints over 52 weeks through targeting IL-17A with IXE than TNF-α with ADA, which is noteworthy given prior comparable musculoskeletal outcomes for both drug classes.

2024-02-06·Expert opinion on biological therapy

Clinical use of biologics for Crohn's disease in adults: lessons learned from real-world studies.

Review

作者: Antonio Tursi ; Giammarco Mocci ; Angelo Del Gaudio ; Alfredo Papa

INTRODUCTION:

The therapeutic armamentarium for managing Crohn's disease (CD) has expanded significantly in recent decades. Several biologics with three different mechanisms of action [anti-tumor necrosis factor (TNF)-α, anti-integrin α4β7, and anti-IL 12/23] are currently available to manage CD.

AREA COVERED:

This narrative review aims to summarize the most significant efficacy and safety data on the use of infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ) and ustekinumab (UST) for the treatment of CD obtained from studies conducted in the real world (RW), compared to the results of randomized clinical trials (RCTs).

EXPERT OPINION:

RW studies reported that biologic agents included in this analysis have higher remission rates and lower adverse event rates than findings from RCTs for treating patients with CD. All biological agents have proven effective and safe in RW studies, even when using biosimilars or switching to subcutaneous administration of the molecules for which they are available. Finally, anti-TNF-α agents, particularly IFX, have a higher rate of adverse events (AEs) than VDZ and UST. Therefore, patients at higher risk of AEs may benefit from other biologics than anti-TNF-α. However, further long-term RW studies are needed to confirm these findings.

项与阿达木单抗生物类似药(Sandoz) 相关的新闻（医药）

2024-04-07

·赛柏蓝

裁员、退出中国部分业务，这家药企怎么了？

编者按：本文来自药智头条，作者葵花籽；赛柏蓝授权转载，编辑yuki据行业网站BioSpace报道，由于其Humira（阿达木单抗）生物类似药Cyltezo在美国的销售额不及预期，勃林格殷格翰宣布将裁减部分销售人员。01艾伯维原研地位难以撼动勃林格殷格翰尚未公布具体裁员人数，但表示计划削减面向客户的销售团队，转而过渡到混合销售模式，包括面对面（F2F）和虚拟经营。据报道，勃林格殷格翰改变销售方式的决定很大程度上是受药品福利管理公司的推动，这些公司将Humira保留在可报销的药物名单上。相对于勃林格殷格翰开发的Cyltezo等Humira生物类似药，患者大多更青睐品牌产品。Humira由艾伯维开发并进行商业化生产，是一种针对并阻断TNF蛋白的单克隆抗体。2002年12月，美国FDA首次批准Humira用于治疗类风湿性关节炎，此后该疗法又获得了其他免疫介导和炎症性疾病的多个适应症，包括克罗恩病、斑块型银屑病和溃疡性结肠炎等。随着获得多项适应症批准，加之风险获益特征显著，Humira迅速成为艾伯维的支柱产品，并成为全球最畅销的药物之一，连续多年稳居榜首。在2022年达到销售额顶峰，为艾伯维贡献了超210亿美元营收。然而，随着近年来失去大部分专利保护，Humira的市场主导地位受到了潜在威胁。2023年，Humira的全球销售额为144亿美元，较2022年的最高点下降了32.2%。艾伯维将销售额下滑归因于其市场受到侵蚀。基于此，全球多家生物类似药开发商便试图利用这一机会，接连推出Humira生物类似药。2023年1月，安进推出了Amjevita，打开了生物类似药市场的大门。这批生物类似药包括Celltrion的Yuflyma、山德士的Hyrimoz、欧加隆/三星生物的Hadlima以及勃林格殷格翰的Cyltezo。而Cyltezo在同类产品中脱颖而出，曾获得FDA可互换性认证，无需更改处方或咨询处方医生，即可替代参考品牌产品。对此，部分分析师将其誉为该领域的“里程碑式成就”。此外，勃林格殷格翰针对Cyltezo提供了大幅折扣，于2023年10月推出了非品牌版本，售价比Humira低81%。尽管如此，艾伯维仍然牢牢把握着市场的统治权，据Samsung Bioepis公司于2024年1月发布的第四期《生物类似药市场报告》（Biosimilar Market Report），艾伯维仅将修美乐2%的市场份额拱手让给了生物类似药竞争对手。02退出中国区卒中康复业务艾伯维难以撼动的原研地位迫使勃林格殷格翰在美国区作出了裁员决定，但其近期碰的壁并不止在美国区，中国区业务也陷入了困境。2024年4月1日，勃林格殷格翰旗下品牌“霁达康复”在官网宣布，因公司战略布局调整，决定退出在中国的卒中康复业务。退出中国区卒中康复业务后，勃林格殷格翰表示还将继续深耕卒中领域，并加速创新疗法的开发，惠及更多中国卒中患者。此外，自4月1日起，霁达康复官方网站、“勃林格殷格翰霁达”官方微信、“成都霁达康复”官方微信、“霁达云康服务”微信小程序、“云小康”官方小红书以及其他霁达康复相关账号也将停止服务与运营。霁达云康医生端/患者端App将持续运营至2024年6月30日为最后一位患者完成服务。根据《中国脑卒中防治报告（2023）》，我国40岁及以上人群脑卒中现患人数达1242万，且发病人群呈年轻化。我国平均每10秒就有1人初发或复发脑卒中，每28秒就有1人因脑卒中离世；幸存者中，约75%留下后遗症、40%重度残疾。然而中国脑卒中患者在一周内接受康复治疗的仅有11.5%，而有42.4%的患者中风后没有接受过任何康复治疗。一方面，目前中国患者及家属更多关注的是脑卒中的急救，对于康复治疗意识有待加强；另一方面，由于水土不服、价格昂贵、患者接受度不高，再加上招聘了100多名销售人员，产出却不高，导致维持成本过高，勃林格殷格翰霁达康复业务难以为继。03小结美国修美乐生物类似药赛道引擎轰鸣，在众多Humir模仿者中，勃林格殷格翰的Cyltezo因其可互换性标签而脱颖而出，使其可以直接替代药房柜台的原始Humira。但即使有如此抗打功力，Cyltezo仍敌不过原研，而赛道其他选手表现将如何？值得期待。END内容沟通：13810174402医药代表交流群扫描下方二维码加入银发经济市场机遇交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联

生物类似药专利到期

2024-04-05

·BioSpace

Boehringer Ingelheim Cuts Staff Due to Low Humira Biosimilar Sales: Reuters

Pictured: Boehringer Ingelheim's headquarters in Silicon Valley/iStock, Sundry Photography Boehringer Ingelheim is laying off some of its sales staff due to the slow uptake of its Humira (adalimumab) biosimilar Cyltezo (adalimumab-adbm) in the U.S., according to reporting from Reuters. The company declined to reveal how many of its employees will be affected by the layoffs but has said that it plans to cut back on customer-facing sales teams and instead transition to a hybrid model, including face-to-face and virtual operations. Boehringer’s decision to change its sales approach was driven in large part by pharmacy benefit managers, which have kept Humira on their list of drugs available for reimbursement, according to Reuters. Patients have largely favored the branded product over biosimilars like Boehringer’s Cyltezo. Owned and commercialized by AbbVie, Humira is a monoclonal antibody that targets and blocks the TNF protein, which is a key player in the inflammatory cascade. The FDA first approved Humira in December 2022 for the treatment of rheumatoid arthritis, and the treatment has since secured several indications for other immune-mediated and inflammatory disease, such as Crohn’s disease, plaque psoriasis and ulcerative colitis. With several approvals under its belt and a strong risk-benefit profile, Humira quickly became one of AbbVie’s best-performing assets. The treatment is also among the world’s top-selling drugs, clinching the top spot for several years. At its peak in 2022, Humira brought in more than $21 billion in annual sales. However, losing most of its patent protections in recent years has potentially threatened Humira’s market dominance. In 2023, Humira only generated $14.4 billion in sales worldwide, a 32.2% decline from its high the prior year. AbbVie attributed the sales hit to the erosion of its market. Several biosimilar developers have sought to take advantage of the opportunity and come out with their copycat versions of the blockbuster drug. Amgen opened the floodgates in January 2023 with the debut of Amjevita, followed by a flurry of launches in July 2023. This batch included Celltrion’s Yuflyma, Sandoz’s Hyrimoz, Oraganon and Samsung Bioepis’ Hadlima and Boehringer’s Cyltezo. Boehringer’s Humira biosimilar stands out from its peers for also having the FDA’s interchangeability designation, which allows it to be substituted for the reference branded product without needing to change the prescription or consult the prescriber. The company has also offered steep discounts for Cyltezo, launching an unbranded version in October 2023 that sells for 81% lower than Humira’s price. Still, AbbVie has kept its tight grip on the market, surrendering only 2% of its massive share to its biosimilar competitors, according to Samsung Bioepis’ 4th Biosimilar Market Report published in January 2024. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

上市批准生物类似药

2024-03-30

·药时代

如果失去"自免TOP 1"，艾伯维会被谁取代？

正文共2741字共5图预计阅读时间：10分钟专利到期的“老药王”修美乐还是“自免TOP 1”吗？财报季落幕，修美乐果然无缘药王。但在自免领域，修美乐仍然处于榜首位置，领先第二名度普利尤单抗（由赛诺菲&再生元研发）近30亿美元，排名第三的则是出自强生的乌司奴单抗。从上述数据来看，第一与第二差距并不算大，而在自免领域30亿美元的单品也并不罕见，难道自免一哥的位置要换人坐了吗？艾伯维：没有“药王”也是一哥累积超过2000亿美元的销售额让修美乐在自免领域封神，艾伯维也因此长居自免领域金字塔顶端，得荣誉称号“自免一哥”。2023年，修美乐在美国的专利到期，包括Amjevita、Yuflyma、Hyrimoz、Cyltezo和Hadlima在内的生物类似药涌入美国市场。美国市场一向是修美乐的重点关注，贡献了大部分营收。据悉，2022年时修美乐在美国的营收达到其巅峰值186.19亿美元，远超同期其他地区总和（26.18亿美元）。为避免出现收入大幅跳水的情况，艾伯维与美国PBM巨头ExpressScripts 和 OptumRx达成协议，通过定价策略确保了修美乐在福利药房中的优先地位。三星Bioepis报告显示，截至2023年12月，修美乐在美国的市场份额仅被占去了不到3%。从市场份额看似损失不大，但2023年修美乐在美国地区的销售额同比锐减35%，从186.19亿美元降至144.04亿美元。图片来源：三星Biologics官网那2024年修美乐还能保住榜首的位置吗？这一点取决于其本身的下沉速度和对手的成长速度。若2024年修美乐的营收依然保持35%（2023年修美乐所有地区同比下降幅度）的降幅，那预计2024年修美乐营收将跌破百亿美元，让出榜首之位似乎是必然结果。但一般来讲，一款药品专利到期后，其跌幅大概率会逐年递增，曾经的药王立普妥就是很好的例子。同时，鉴于医保机构和保险公司对生物类似药的认可度提升及更多生物类似药上市，修美乐的市场份额必定进一步萎缩，35%的降幅或许还是保守了些。2023年，艾伯维自免板块共营收261.36亿美元，仍然当之无愧的“免疫一哥”。而让艾伯维依然能稳坐一哥位置的原因，要说回到艾伯维的自免长期战略，此战略的核心在于：培育“新人”。图片来源：艾伯维官网目前，艾伯维还另有两款潜力产品进入商业化。Risankizumab（Skyrizi）是一款IL-23拮抗剂，自2019年上市以来表现抢眼，陆续获批用于治疗中重度斑块型银屑病（PsO）、银屑病关节炎（PsA）及克罗恩病（CD）。上市五年内其营收持续增长，2023年达到77.63亿美元，同比增长51%。一款药品上市后的放量期一般在3~5年，Skyrizi在上市后的第五年还能保持50%的增长已是难得。而根据艾伯维官网信息，2023年Skyrizi有五项重要临床试验均得到积极结果，其中包括与Otezla（安进开发的银屑病新药）及Stelara（强生的尤斯泰金单抗）的头对头研究。随着适应症可及范围和准入地区的不断扩大，Skyrizi的营收能力或许还有不少增长空间。另一款关键产品乌帕替尼（Rinvoq，全球首款JAK1选择性抑制剂）自2019年获批治疗类风湿性关节炎后，营收多次翻倍增长，是不少分析师看好的自免领域下一个百亿美元单品。2023年Rinvoq的营收达到39.69亿美元，同比增长58%。目前关于其的多项III期临床试验正在进行中，覆盖了白癜风、重度斑秃、系统性红斑性狼疮，大动脉炎等适应症，除此之外Rinvoq与度普利尤单抗的正面交锋也在进行中。结合Skyrizi和Rinvoq的强劲增长势头，预计2024年这两款产品总营收将超越修美乐，艾伯维自免板块整体营收在2024年将保持与2023年相近水平。除此之外，艾伯维也有其他还在临床阶段的自免产品，近期还收购了Landos Biopharma，并于三家专注炎症药物开发的公司（Parvus 、OSE Immunotherapeutics及entarix Biotherapeutics）达成合作。长期来看，艾伯维自免板块展现出稳健过渡与持续发展的态势。强生：我是第二名2023年，强生自免板块共营收180.52亿美元，位列第二。但在自免这一块，强生和艾伯维面临一样的困境，即专利到期。Stelara（乌司奴单抗）是强生自免板块的顶梁柱，于2009年上市，目前已获批PsO、PsA、CD、中重度活动性溃疡性结肠炎（UC）等多个适应症。2023年9月，Stelara的一项关键专利到期。有趣的是，Stelara的营收不减反增，并首次突破百亿美元大关。一般来说，一款品牌药专利到期前，模仿者早就准备好一切，侯在监管机构的后台只等入场。面对危机，强生选择了通过和安进等公司达成协议，直接解决对手，推迟了Stelara生物类似药在美国的上市时间。安进作为其中之一，同意在2025年1月1日前不推出对应生物类似药。这是Stelara能有正增长的主要原因。保证了美国市场的暂时太平，Stelara今后一年的营收减少则主要体现在欧洲市场。而随着Stelara的生物类似药于2024年陆续在欧洲上市，Stelara的市场份额将相应缩减。但考虑到美国市场仍是Stelara营收大头，约占2/3，因此在其生物类似药在美国上市之前，Stelara的营收并不会出现大幅跳水情况。除了Stelara，强生的自免板块还有三款营收超10亿美元的产品，即Tremfya，Simponi/Simponi aria及Remicade。图片来源：强生官网Tremfya（古塞奇尤单抗）是一款IL-23单抗，2017年获FDA批准用于PsO。无论是从营收增长幅度还是营收总额来看，Tremfya都是强生除了王牌之外目前最强的单品，但其增长势头已现放缓迹象，预计2024年营收增长有限。Simponi/Simponi aria（戈利木单抗）是一款TNF拮抗剂，2009年获FDA批准，覆盖RA、PsA、AS和UC等适应症。得益于较低的给药频率和便捷的给药方式，上市十五年间Simponi/Simponi aria的营收保持稳定增长。目前强生已将关键专利延期至2026年，短期内不会面临营收下降风险。但结合其近年营收增幅，预计其2024年营收波动不大，与此前持平。Remicade（英夫利昔单抗）是一款TNFα单抗，于1998年获批，曾也是强生的拳头产品，最高营收达69.66亿美元。自2016年起，随着生物类似药的涌入，Remicade营收以年均约-10%的速度快速下滑。根据强生财报，2023年Remicade共营收18.39亿美元，同比下降21%，颓势难以逆转。总体而言，强生的自免产品线中亮点不多，预计2024年自免板块整体营收将在2023年的基础上小幅波动。赛诺菲：手握"2024年度自免TOP1单品"在修美乐和Stelara受生物类似药影响，营收必然缩减的情况下，“2024年度自免TOP1”的位置似乎非Dupixent（度普利尤单抗）莫属。Dupixent是全球首款获批上市的IL-4R单抗药物，由赛诺菲和再生元联合开发，于2017年被FDA批准上市，用于中重度特应性皮炎。上市后，得益于不断扩大的适应症范围，Dupixent的营收一直以迅猛的势头快速增长。根据赛诺菲2023年报，Dupixent年营收107.15亿欧元，约合115.72亿美元（按1：1.08的汇率计算）。2023年，Dupixent关于慢性阻塞性肺病（COPD）的III期临床试验得出积极结果，优异的表现让业界对这款产品十分看好。根据赛诺菲公开信息，2024年Dupixent的营收有望达到130亿欧元，约合140亿美元，即同比增长21%。2023年，赛诺菲自免相关产品共营收约130亿欧元（约140亿美元）。除了Dupixent，赛诺菲自免板块另外几款产品目前并未表现出百亿单品的潜力，2023年营收均未超过10亿欧元。其中，营收最多的Aubagio是一款口服免疫调节剂，主要用于治疗多发性硬化症（MS），目前正处于高速下滑期。图中高亮部分为赛诺菲自免相关产品（图片来源：赛诺菲官网）比较值得期待的是Sarclisa（艾沙妥昔单抗），一款CD38单抗，于2020年被FDA批准上市，用于多发性骨髓瘤的治疗。从上述情况来看，赛诺菲的自免板块目前仅有Dupixent一款重磅产品支撑。Dupixent或许将取代修美乐，但短期内赛诺菲离“自免一哥”还有很长一段路要走。对于赛诺菲来讲，2027年或许才是其扭转身份的节点。根据赛诺菲在2023年全球投资者研发日活动上所公布的消息，未来赛诺菲将大力推进自免板块业务，预计将有不少重磅事件在2027年或之前发生。图片来源：赛诺菲官网小结新陈交替，万物发展的必然规律。将视线放到更远的以后，修美乐不会是永远的自免TOP 1，自免一哥的位置也不会永远独属一人。存在良性竞争才有机会解锁更多机遇。参考资料1.各公司官网2.其他公开资料封面图来源：PIXABAY版权声明/免责声明本文为团队原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn从 “皇帝新衣”撤市和历史首封特殊CRL看FDA加速批准《生物安全法案》阴影下的药明生物，2023年年报需要回应哪些事？一天三笔并购，总额不过20亿美元！第三家中国biotech被外企全部收购点击阅读原文，了解更多！

财报生物类似药专利到期

100 项与阿达木单抗生物类似药(Sandoz) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB04	DB00051

研发状态

适应症	最高研发状态	国家/地区	公司
葡萄膜炎	批准上市	美国更多	Sandoz, Inc. 更多
克罗恩病	批准上市	美国更多	Sandoz, Inc. 更多
溃疡性结肠炎	批准上市	美国更多	Sandoz, Inc. 更多
类风湿关节炎	批准上市	美国更多	Sandoz, Inc. 更多
化脓性汗腺炎	批准上市	美国更多	Sandoz, Inc. 更多

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临床结果

适应症

分期

评价

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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


NCT02016105 (Pubmed \| Br J Dermatol) 人工标引	临床3期	银屑病	465	GP2017	膚壓願選壓衊廠觸網糧(獵鑰顧壓淵簾鏇窪餘觸) = 糧鏇製獵觸壓顧簾糧構齋蓋膚窪鑰選鹽構襯範 (糧選鹽醖廠壓鹹壓鏇蓋 ) 更多	相似	2018-09-01
				ref-ADMB	膚壓願選壓衊廠觸網糧(獵鑰顧壓淵簾鏇窪餘觸) = 鬱鹽蓋壓鏇壓蓋築窪醖齋蓋膚窪鑰選鹽構襯範 (糧選鹽醖廠壓鹹壓鏇蓋 ) 更多
EULAR2021	N/A	银屑病 \| 类风湿关节炎	-	SDZ-ADL (GP2017)	餘積製顧窪壓膚鏇鹹窪(顧簾鏇顧蓋鏇夢齋齋壓) = 廠齋蓋襯願艱醖鹽醖蓋齋窪積壓襯繭獵鑰鑰壓 (鏇鹹糧襯鏇窪選壓蓋膚 )	-	2021-06-02
NCT02744755 (ADMYRA, Pubmed \| BioDrugs) 人工标引	临床3期	类风湿关节炎	353	Adalimumab-ADAZ	(製鹹鏇築製鏇蓋壓糧夢) = 淵壓艱廠築鑰遞齋壓襯觸淵觸鑰壓壓簾簾夢顧 (夢鑰鬱窪糧獵繭選鑰顧 ) 更多	相似	2020-12-01
				adalimumab	(製鹹鏇築製鏇蓋壓糧夢) = 鑰淵蓋艱顧醖憲積鹹糧觸淵觸鑰壓壓簾簾夢顧 (夢鑰鬱窪糧獵繭選鑰顧 ) 更多
NCT02016105 (CTgov)	临床3期	斑块状银屑病	465	GP2017 Adalimumab (GP2017 Adalimumab)	膚艱鹽衊遞顧顧醖鑰繭(餘蓋獵製遞鬱鑰鑰顧築) = 夢顧築衊鬱鏇糧獵鏇獵窪鑰窪製淵積廠構鑰鹽 (鑰鹽衊構憲鏇鹹廠鑰衊, 醖簾簾顧遞鹽築簾窪糧 ~ 顧選願憲獵膚鹹壓製願) 更多	-	2017-04-07
				Humira ® Adalimumab (Humira ® Adalimumab)	膚艱鹽衊遞顧顧醖鑰繭(餘蓋獵製遞鬱鑰鑰顧築) = 鹽構鏇繭糧鬱構願願窪窪鑰窪製淵積廠構鑰鹽 (鑰鹽衊構憲鏇鹹廠鑰衊, 鏇齋範壓鬱夢選簾網觸 ~ 網製觸獵遞鏇淵蓋淵憲) 更多