Targeted Treatment Early With Etanercept Plus Methotrexate Versus T2T Care for DMARD-naïve Early RA Patients. A Prospective, Longitudinal Cohort Study With Embedded Pilot Randomised Controlled Trial to Assess Treatment Rationalisation Based on naïve T-cell Stratification.

The main aim of the study is to determine the clinical utility of naive T-cell stratification for rationalising treatment with methotrexate (MTX), for DMARD-naive early RA patients. Thus, it aims to determine whether TNFi therapy (Benepali) instituted as first-line therapy in DMARD-naive early RA patients with poor T-cell prognostication confers better outcomes (clinical, structural and immunological). Hence, this would enable early targeted treatment for those with a poorer prognosis based on their immunological status.

开始日期2019-03-01

申办/合作机构

University of Leeds

[+1]

ACTRN12618000279224 / Completed临床4期

An Assessor-blind, randomised, parallel non-inferiority trial to compare multiple switching of Brenzys® (etanercept biosimilar) and Enbrel® (etanercept reference product) versus non-switching Enbrel® in maintaining efficacy of Enbrel® in participants with rheumatoid arthritis

开始日期2018-04-19

申办/合作机构-

NCT03470688 / Unknown statusN/AIIT

An Observational Study Designed to Investigate the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents in Australian Rheumatology

An observational study investigating the utilisation and effectiveness of originator and biosimilar anti-TNF agents in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.

开始日期2018-03-01

申办/合作机构

Opal Rheumatology Ltd.

[+1]

100 项与依那西普生物类似药(Samsung Bioepis Co., Ltd.) 相关的临床结果

登录后查看更多信息

100 项与依那西普生物类似药(Samsung Bioepis Co., Ltd.) 相关的转化医学

登录后查看更多信息

100 项与依那西普生物类似药(Samsung Bioepis Co., Ltd.) 相关的专利（医药）

登录后查看更多信息

项与依那西普生物类似药(Samsung Bioepis Co., Ltd.) 相关的文献（医药）

2024-01-09·Ocular immunology and inflammation

Efficacy and Safety of Switching from Adalimumab Originator to SB5, Adalimumab Biosimilar for Noninfectious Uveitis.

Article

作者: Seok Hyeon Song ; Se Joon Woo

PURPOSE:

To evaluate the efficacy and safety of switching from adalimumab originator (Humira, AbbVie) to SB5, adalimumab biosimilar (Adalloce, Samsung Bioepis) in patients with noninfectious uveitis (NIU).

METHODS:

Fifteen patients (29 eyes) with NIU who were switched from adalimumab originator to SB5 and followed up for 6 months or longer were retrospectively included. Data consisted of best-corrected visual acuity (BCVA, logMAR), intraocular pressure (IOP, mmHg), anterior chamber (AC) cell grade, anterior vitreous (AV) cell grade, vitreous haze grade, central macular thickness (CMT, μm), and macular volume (MV, mm³) at pre-switching, 2, 4, and 6 months post-switching.

RESULTS:

There were no significant differences in BCVA, AC and AV cell grades, and vitreous haze grades at 2, 4, and 6 months post- compared with pre-switching, and no significant differences in CMT and MV at 2 and 6 months post-switching. CMT and MV decreased from 260.55 ± 67.44 μm and 8.37 ± 1.14 mm³ at pre-switching to 244.14 ± 60.31 μm (p = 0.032) and 8.11 ± 1.20 mm³ (p = 0.027) at 4 months post-switching, respectively. There was no recurrence of uveitis, as defined by AC cell grade, vitreous haze, or BCVA. Four patients (27%) were switched back to adalimumab originator after a mean of 9 weeks, due to discomfort during the injection (three patients) and technical difficulty with the new injection device (one patient). No other adverse events occurred after switching to SB5.

CONCLUSION:

Switching from adalimumab originator to SB5 for NIU does not result in clinically significant differences in treatment efficacy and safety.

2023-12-19·Reumatismo

Anti-tumor necrosis factor α: originators versus biosimilars, comparison in clinical response assessment in a multicenter cohort of patients with inflammatory arthropathies.

Article

作者: C Gioia ; A Picchianti Diamanti ; R Perricone ; M S Chimenti ; A Afeltra ; L Navarini ; A Migliore ; U Massafra ; V Bruzzese ; P Scolieri ; C Meschini ; M Paroli ; R Caccavale ; P Scapato ; R Scrivo ; F Conti ; B Laganà ; M Di Franco

OBJECTIVE:

To compare etanercept and adalimumab biosimilars (SB4 and ABP501) and respective bioriginators in terms of safety and efficacy in a real-life contest.

METHODS:

We consequently enrolled patients affected by rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, treated with SB4, and ABP501, or with corresponding originators, belonging to the main biological prescribing centers in the Lazio region (Italy), from 2017 to 2020. Data were collected at recruitment and after 4, 8, 12, and 24 months of therapy.

RESULTS:

The multicenter cohort was composed by 455 patients treated with biosimilars [SB4/ABP501 276/179; female/male 307/146; biologic disease-modifying anti-rheumatic drug (b-DMARD) naïve 56%, median age/ interquartile range 55/46-65 years] and 436 treated with originators (etanercept/adalimumab 186/259, female/ male 279/157, b-DMARD naïve 67,2%, median age/interquartile range 53/43-62 years). No differences were found about safety, but the biosimilar group presented more discontinuations due to inefficacy (p<0.001). Female gender, being a smoker, and being b-DMARD naïve were predictive factors of reduced drug survival (p=0.05, p=0.046, p=0.001 respectively). The retention rate at 24 months was 81.1% for bioriginators and 76.5% for biosimilars (median retention time of 20.7 and 18.9 months, respectively) (p=0.002). Patients with remission/low disease activity achievement at 4 months showed a cumulative survival of 90% to biosimilar therapy until 24 months (p=0.001); early adverse reactions instead represented a cause of subsequent drug discontinuation (p=0.001).

CONCLUSIONS:

Real-life data demonstrated a similar safety profile between biosimilars and originators, but a reduced biosimilar retention rate at 24 months. Biosimilars could be considered a valid, safe, and less expensive alternative to originators, allowing access to treatments for a wider patient population.

2023-02-01·Arthritis care & research

Effectiveness and Persistence in SB4 and Reference Etanercept-Treated Rheumatoid Arthritis Patients in Ordinary Clinical Practice in Norway.

Article

作者: Glenn Haugeberg ; Gunnstein Bakland ; Erik Rødevand ; Inger Johanne Widding Hansen ; Andreas Diamantopoulos ; Are Hugo Pripp

OBJECTIVE:

Biosimilars represent cost-effective alternatives to reference biologic disease-modifying antirheumatic drugs (bDMARDs). In the treatment of rheumatoid arthritis (RA), the etanercept biosimilar SB4 demonstrated equivalent efficacy/similar safety compared with reference etanercept in a phase 3, randomized controlled trial. We applied EULAR Points to Consider for Comparative Effectiveness Research in a retrospective database study of etanercept and SB4 in patients treated in clinical practice in Norway.

METHODS:

Patients with RA (N=1455) treated with etanercept or SB4 between 2010-2018 at five centers in Norway with ≥1 year of follow-up were included. Disease outcomes (DAS28 at week [W]52) and drug persistence were compared between unmatched etanercept (N=575) and SB4 (N=299) cohorts and matched analyses (N=172, both cohorts) using propensity-score (PS) matching to adjust for confounders.

RESULTS:

In unmatched analyses, the difference in change from baseline (mean [95% CI]) between etanercept (n=221) and SB4 (n=106) for DAS28 at W52 was -0.02 (-0.32 to 0.27), demonstrating equivalence by the pre-determined equivalence margin (±0.6); in PS-matched analyses, the difference between etanercept (n=49) and SB4 (n=49) was 0.03 (-0.46 to 0.52) and within the pre-defined equivalence margin. Persistence (95% CI) on drug at W52 was similar between etanercept (0.62 [0.57 to 0.65]) and SB4 (0.66 [0.60 to 0.71]) cohorts in the unmatched analysis; in PS-matched cohorts, persistence at W52 was 0.52 (0.44 to 0.59) for etanercept and 0.68 (0.61 to 0.75) for SB4.

CONCLUSION:

项与依那西普生物类似药(Samsung Bioepis Co., Ltd.) 相关的新闻（医药）

2024-02-20

·药融圈

渤健财报解读

▲3月7-8日成都生物医药创新者峰会 · 点击立即报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。2月13日，美国biotech渤健公司发布了2023年财报，该公司全年营收98.36亿美元，同比下降2%，其中四季度营收23.86亿美元，同比下降6%。其业绩下滑的最主要原因是多发性硬化管线销售额下降，多发性药物共卖出54.30亿美元，同比下降14%。该公司在2023年的销售成本为25.33亿美元，占销售额的26%，毛利水平为74%，相比去年同期下降4%。研发投入24.62亿美元，约占销售额的25%，市场和一般管理费22.77亿美元，约占销售额的23%。因为毛利下降和研发投入增加，该公司的利润水平出现了明显下降，2023年净利润为11.62亿美元，仅为销售额的11.80%。渤健的业务营收分为三个部分，包括产品销售收入、产品授权费、CMO费，分别收入72.47亿美元、16.90亿美元和8.99亿美元。而产品销售收入又主要来自多发性硬化管线、罕见病管线和生物类似药管线，2023年净销售额分别为46.62亿美元、18.03亿美元和7.70亿美元。多发性硬化方面，富马酸二甲酯（TECFIDERA）因为专利已经失效，仅卖出10.13亿美元，相比去年同期销售额下降4亿多美元；VUMERITY是为了应对TECFIDERA专利悬崖而开发的505b2，全年卖出5.76亿美元，几乎相比去年同期持平。β干扰素（AVONEX）是渤健卖了20年的老产品，2023年营收8.11亿美元，相比去年同期也出现了下降。PLEGRIDY是AVONEX的升级品，2023年销售额为2.94亿美元，相比去年同期也存在下降。那他珠单抗(TYSABRI) 营收18.77亿美元，相比去年同期下降约2亿美元，氨吡啶缓释片(Fampridine）虽未出现销售额下滑，但营收不足1亿美元。罕见病管线方面，渤健拥有诺西那生钠(Spinraza）、Qalsody(tofersen)和Skyclarys(omaveloxolone)三款药物，全年营收分别为17.41亿美元、0.06亿美元和0.6亿美元，整个管线销售额几乎与去年持平。生物类似物方面，渤健主要有BENEPALI（依那西普）、IMRALDI（阿达木单抗）、英夫利昔单抗（FLIXABI）和BYOOVIZ（雷珠单抗）四款产品，2023年销售额分别为4.39亿美元、2.22亿美元、0.77亿美元和0.32亿美元，biosimilar总销售额几乎与去年同期持平。相关阅读诺和诺德2023年财报：司美格鲁肽大卖212亿美元诺华2023年业绩：营收454亿美元，同比增长10%GSK 2023年业绩：营收303亿英镑，盈利能力大幅提升辉瑞公布2023年业绩：营收同比下降42%，净利润同比下降93%强生2023年业绩公开，营收852亿美元，同比增长6.5%（附产品销售额）默沙东营收601亿美元，其中药王K药大卖250亿美元赛诺菲2023年营收431亿欧元，Dupixent突破110亿美元，氯吡格雷和甘精胰岛素在中国逆势增长再生元财报：度普利尤单抗卖出116亿美元，阿柏西普94亿美元艾伯维财报：修美乐销售额大幅下跌，正式让出药王宝座罗氏年报：营收下降7%，净利润下降9%礼来财报：GLP-1大卖125亿美元Vertex：囊性纤维化药物比增长11%，破百亿在即吉利德公开业绩：营收271亿美元，其中CAR-T 19亿美元安进2023年业绩：营收282亿美元，同比增长11%阿斯利康2023：中国区收入423亿元，增长7%BMS业绩：总营收450亿美元，同比下降2%版权声明：本文转自药事纵横，如不希望被转载的媒体或个人可与我们联系，我们将立即删除活动推荐 3月 • NDC x 2024新药创新者峰会关键词： ADC，改良型新药，小分子新药，GLP-1药物（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

财报生物类似药

2024-01-21

·药融圈

投资2.5亿！重庆普佑制药医药中间体及原料药（洛伐他汀、富马酸磷丙替诺福韦、辛伐他汀、替卡格雷、沙库巴曲缬沙坦钠等）

▲3月7-8日成都生物医药创新者峰会 · 点击立即报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。近日，关于重庆普佑制药有限公司医药中间体及原料药（一期）在相关网站公示。项目基本情况项目名称：医药中间体及原料药（一期）建设单位：重庆普佑制药有限公司建设地点：万州经济技术开发区九龙园龙翔北路建设性质：新建工程投资：25000万元，其中包括环保投资1000万元建设工期：2年占地面积和建筑面积：占地面积约211亩，一期工程建筑面积24671.94m2产品方案项目涉及11个医药中间体，建成后达到2275.51t/a的生产规模。备注：TA-2（（R）-（1-（6-氨基-9H-嘌呤-9-基）丙-2-基）氧基）甲基）膦酸，CAS：147127-20-6，用于生产富马酸磷丙替诺福韦）TAA-1（6-氨基-9-(2-丙酮基)嘌呤，CAS：105970-02-3，用于TAA生产）SV（辛伐他汀，CAS：79902-63-9）TAA（（R）-1-（6-氨基-9H-嘌呤-9-基）丙-2-醇，CAS：14047-28-0，用于TA-2生产）SV-2（（3R，5R）-3,5-二羟基-7-（（1S，2S，6R，8S）-8-羟基-2,6-二甲基-1,2,6,7,8,8-六氢萘-1-基）庚酸，CAS：132748-10-8，用于SV生产）TGM1-2（（（3aR，4R，6aR）-6-甲氧基-2,2-二甲基四氢呋喃[3,4-d][1,3]二氧基-4-基）甲醇，CAS：72402-14-3，用于TGM1-3生产）TGM1-3（（（3aR，4R，6aR）-6-甲氧基-2,2-二甲基四氢呋喃[3,4-d][1,3]二氧基-4-基）甲基-4-甲基苯磺酸酯，CAS：4137-56-8，用于TGM1-4生产）TGM1-4（（3aS，4S，6aR）-4-（碘甲基）-6-甲氧基-2,2-二甲基四氢呋喃[3,4-d][1,3]二噁戊烷，CAS：38838-06-1，用于TGM1-5生产）TGM1-11（2-(((3aS,4R,6S,6aR)-6-氨基-2,2-二甲基四氢-3HH-环戊二烯并[d][1,3]二氧杂环戊烯-4-基)氧基)乙醇(2S,3S)2,3-二羟基琥珀酸酯（简称：TGM1酒石酸盐），CAS：2376278-72-5，用于合成替卡格雷）TGM3-2（2-氯-1-（3,4-二氟苯基）乙烷-1-酮，CAS：51336-95-9，用于 TGM3-3 生产）SB-4（（R，E）-5-（[1，1'-联苯]-4-基）-4-（（叔丁氧基羰基）氨基）-2-甲基戊-2-烯酸乙酯，CAS：2131788-25-3，用于 SB-5 生产）SB-6（产品名称：4-（（（2S）-1-（[1，1'-联苯]-4-基）-5-乙氧基-4-甲基-5-氧代戊烷-2-基）氨基）-4-氧代丁酸，CAS：149709-62-6，用于合成沙库巴曲钠）重庆普佑制药有限公司成立于2022年11月，由南京鸿兴生物医药有限公司和几位自然人组建而成。坐落于万州经开区九龙园区，专门从事特色医药中间体的研发、生产与销售，并提供合同研发与合同生产服务。南京鸿兴生物医药有限公司专注于高端医药原料药和关键中间体研发、生产和销售。版权声明：本文转自原料药情报局，如不希望被转载的媒体或个人可与我们联系，我们将立即删除活动推荐 3月 • NDC x 2024新药创新者峰会关键词： ADC，改良型新药，小分子新药，GLP-1药物（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

申请上市

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

100 项与依那西普生物类似药(Samsung Bioepis Co., Ltd.) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB01	DB00005

研发状态

适应症	最高研发状态	国家/地区	公司
多关节型幼年特发性关节炎	批准上市	美国更多	Samsung Bioepis Co., Ltd. 更多
银屑病关节炎	批准上市	美国更多	Samsung Bioepis Co., Ltd. 更多
斑块状银屑病	批准上市	美国更多	Samsung Bioepis Co., Ltd. 更多
类风湿关节炎	批准上市	美国更多	Samsung Bioepis Co., Ltd. 更多
强直性脊柱炎	批准上市	美国更多	Samsung Bioepis Co., Ltd. 更多

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


EULAR2018	N/A	风湿性疾病 anti-drug antibodies (ADAbs) \| neutralising antibodies (nAbs)	-	SB2	簾廠築築範鹽遞糧獵醖(積憲構鏇鹽構築築夢範) = 鏇窪積獵選蓋選齋鑰選簾遞觸顧鏇膚遞繭夢遞 (簾壓遞鬱鑰網製簾艱範 )	-	2018-06-13
				CT-P13	簾廠築築範鹽遞糧獵醖(積憲構鏇鹽構築築夢範) = 齋遞獵壓齋壓艱襯餘憲簾遞觸顧鏇膚遞繭夢遞 (簾壓遞鬱鑰網製簾艱範 )
EULAR2021	N/A	-	9,274	Etanercept	(遞襯鹽製築積衊鏇夢簾): HR = 0.87 (95% CI, 0.79 ~ 0.95)	积极	2021-06-02
				SB4
NCT01895309 (Pubmed \| Arthritis Rheumatol) 人工标引	临床3期	类风湿关节炎	596	SB4	(獵醖願鬱製鏇構網窪窪) = 齋鏇觸鬱窪憲廠壓醖獵夢獵窪鹽鏇製網鬱艱觸 (觸遞鬱鹽廠襯窪艱顧鬱 ) 更多	相似	2017-01-01
				etanercept	(獵醖願鬱製鏇構網窪窪) = 範選範選繭製顧艱艱網夢獵窪鹽鏇製網鬱艱觸 (觸遞鬱鹽廠襯窪艱顧鬱 ) 更多
NCT01895309 (Pubmed \| Rheumatology (Oxford)) 人工标引	临床3期	类风湿关节炎	596	SB4	(窪構鬱觸鬱鬱鹽鹽範醖) = 衊鏇選獵蓋夢構構淵繭鹹淵膚膚鬱衊夢遞顧鹽 (膚鹽艱製鹹鹹憲構範齋 ) 更多	相似	2017-12-01
				etanercept	(窪構鬱觸鬱鬱鹽鹽範醖) = 選鬱觸願鬱築蓋窪選壓鹹淵膚膚鬱衊夢遞顧鹽 (膚鹽艱製鹹鹹憲構範齋 ) 更多
EULAR2020	N/A	关节炎	477	Etanercept originator	(衊餘顧鑰築醖網獵築淵) = 網艱製夢構蓋憲鏇鬱願壓淵獵鏇夢積淵網構艱 (廠壓鹹選繭糧鑰鑰觸憲 ) 更多	-	2020-06-03
				SB4	(衊餘顧鑰築醖網獵築淵) = 範鹽簾顧範網願鹹網壓壓淵獵鏇夢積淵網構艱 (廠壓鹹選繭糧鑰鑰觸憲 ) 更多
COMPANION-B (Pubmed) 人工标引	N/A	类风湿关节炎	163	SB4	(廠艱鑰觸觸積觸膚築窪) = 鑰鹹衊簾襯願鑰壓觸獵獵壓蓋顧襯積鏇遞廠築 (築壓願襯構窪艱艱簾築, 8.4 ~ 30.9) 更多	积极	2022-09-22
				etanercept	(廠艱鑰觸觸積觸膚築窪) = 鹹鹹襯積齋廠顧鏇鑰繭獵壓蓋顧襯積鏇遞廠築 (築壓願襯構窪艱艱簾築, 15.0 ~ 32.2) 更多
EULAR2018	N/A	-	56	SB4	(範製廠積鏇製築積鑰壓) = 89% (n=8) was due to loss of efficacy, whilst 11% (n=1) reported side effects 醖遞鬱壓憲觸壓淵鏇製 (醖餘願廠夢夢鏇蓋鏇鏇 ) 更多	-	2018-06-13
EULAR2019	N/A	维持	8,149	Etanercept	(壓積壓廠衊鏇網網餘壓) = 積糧製壓壓醖窪膚鬱衊獵壓艱鹹憲選願製鏇製 (製壓蓋淵蓋鑰夢積醖網 )	-	2019-06-12
				SB4	(構糧鬱製淵鏇鏇築遞鏇) = 範鬱構壓廠鏇襯膚願夢網鏇糧遞積製遞廠簾艱 (鑰獵觸鑰遞網獵繭鏇願, 65 ~ 79)
Pubmed \| Arthritis Rheumatol	N/A	-	642	Originator Etanercept	蓋餘鹽獵願築齋廠襯壓(淵構鑰積積製窪鹹製簾): adjusted hazard ratio = 1.57 (95% CI, 1.05 ~ 2.36)	-	2018-09-01
				Biosimilar SB4
EULAR2018	N/A	关节炎	1,641	Originator Etanercept	(積鹹膚鏇製網鏇鏇鹹鹽) = No major safety events occurred 顧餘壓網襯構網餘鏇範 (憲選觸齋範構襯膚構獵 ) 更多	-	2018-06-13
				Biosimilar SB4