A Randomized, Double-Blind, Parallel-Group, Phase I Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 s.c. Compared to Actemra® in Healthy Male Participants

The primary objective of the study is to show equivalence in pharmacokinetics (PK) of BIIB800 and Actemra following SC administration of a single dose to healthy male participants. The secondary objective of the study is to evaluate PK over time, clinical safety, pharmacodynamic (PD) profiles and immunogenicity of BIIB800 and Actemra.

开始日期2024-01-02

申办/合作机构

Biogen, Inc.

NCT05968508

/ Active, not recruiting临床1期

A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects

This is a randomized, double-blind, single-dose, two-arm parallel study to compare the pharmacokinetics, safety and immunogenicity of BAT1806 prefilled subcutaneous injection with RoActemra® (from EU) in healthy male subjects.

开始日期2023-08-29

申办/合作机构

百奥泰生物制药股份有限公司

CTR20232409

/ Active, not recruiting临床1期

一项随机、双盲、单次给药、平行两组BAT1806皮下注射液与雅美罗®在中国健康男性受试者的药代动力学和安全性比对研究

主要研究目的：比较在中国健康男性受试者中单次皮下注射BAT1806皮下注射液或雅美罗®（欧盟），两药之间药代动力学的相似性。次要研究目的：评价BAT1806皮下注射液、雅美罗®（欧盟）在中国健康男性受试者的临床安全性、耐受性及免疫原性。

开始日期2023-08-29

申办/合作机构

百奥泰生物制药股份有限公司

100 项与托珠单抗生物类似药 (百奥泰生物) 相关的临床结果

登录后查看更多信息

100 项与托珠单抗生物类似药 (百奥泰生物) 相关的转化医学

登录后查看更多信息

100 项与托珠单抗生物类似药 (百奥泰生物) 相关的专利（医药）

登录后查看更多信息

项与托珠单抗生物类似药 (百奥泰生物) 相关的文献（医药）

2025-03-01·BIODRUGS

Comparative Structure Activity Relationship Characterization of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab

Article

作者: Liu, Cuihua ; Ebbers, Hans C ; Liu, Suli ; Li, Shengfeng ; Mei, Xiong ; Liu, Yujie ; Xie, Jianhua ; Cao, Di ; Li, Zhuxiang ; Engle, Linda

BACKGROUND:

BAT1806/BIIB800 (Tofidence™/tocilizumab-bavi), a biosimilar of tocilizumab, demonstrated a high degree of analytical and functional similarity to reference tocilizumab (TCZ) in a comprehensive comparative analytical assessment. Minor differences with respect to TCZ were observed for some attributes and this study assessed the potential impact of these differences through structure activity relationship characterization.

METHODS:

Structure activity relationship studies were conducted to assess glycation, glycosylation, charge variants, hydrophobicity, oxidation, and deamidation differences, using a range of investigative techniques. Structure activity relationship studies were performed on one lot each of BAT1806/BIIB800 and TCZ (European Union sourced only) except for glycation, where additional lots sourced from China and the USA were used.

RESULTS:

Average total glycated protein content of BAT1806/BIIB800 was higher than TCZ (10.08% vs 1.19%); however, biological activity, including target binding and functional potency, was unaffected. Stress-induced glycation of BAT1806/BIIB800 and TCZ also did not affect the biological activity of the products despite up to 60% total glycation content. Minor differences were observed between BAT1806/BIIB800 and TCZ in glycosylation, charge variants, hydrophobicity, oxidation, and deamidation without a relevant impact on interleukin-6 receptor binding, Fc-receptor binding, and effector functions. In forced degradation studies, oxidation and deamidation trends were comparable between the two products.

CONCLUSIONS:

Comparative structure activity relationship characterization of BAT1806/BIIB800 and TCZ indicated that there are no relevant differences in quality attributes between BAT1806/BIIB800 and reference TCZ. Observed differences between BAT1806/BIIB800 and TCZ had no functional impact on BAT1806/BIIB800. The results support the conclusion that BAT1806/BIIB800 is similar to TCZ.

2024-09-01·BIODRUGS

Correction to: Demonstration of Physicochemical and Functional Similarity of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab

2024-07-01·BIODRUGS

Demonstration of Physicochemical and Functional Similarity of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab

Article

作者: Ebbers, Hans C ; Liu, Cuihua ; Li, Shengfeng ; Liu, Suli ; Mei, Xiong ; Xie, Jianhua ; Cao, Di ; Liu, Yujie ; Li, Zhuxiang ; Engle, Linda

BACKGROUND AND OBJECTIVE:

Tocilizumab is an immunoglobulin G1 monoclonal antibody targeting the interleukin-6 receptor (IL-6R). BAT1806/BIIB800 (tocilizumab-bavi) has been developed as a biosimilar to the reference product tocilizumab (TCZ). The objective of this study was to demonstrate physicochemical and functional similarity between BAT1806/BIIB800 and TCZ in a comprehensive comparability exercise.

METHODS:

A comprehensive panel of over 20 methods was used to generate datasets comparing critical and non-critical product quality attributes for 10 BAT1806/BIIB800 lots and 44 TCZ lots (16 sourced from China, 16 from the EU, and 12 from the US). Primary structure, higher-order structure, and physicochemical properties were assessed using liquid chromatography, mass spectrometry, various spectroscopy techniques/methods, capillary electrophoresis, and thermoanalytical techniques. Fragment antigen-binding (Fab)- and fragment crystallizable (Fc)-mediated biological properties were assessed using cell-based assays, immunoassays, flow cytometry, and kinetic binding assays.

RESULTS:

BAT1806/BIIB800 and TCZ (irrespective of source) were shown to be similar in terms of structural and functional properties. No differences were observed in terms of the most critical quality attributes, that is, soluble-IL-6R binding and inhibition of IL-6-mediated cell proliferation. BAT1806/BIIB800 and TCZ demonstrated similarity in terms of Fab- and Fc-mediated binding and biological activity. Minor differences were observed in glycosylation (afucosylation and sialylation), glycation, aggregation, and charge variants, which were demonstrated to be not clinically relevant.

CONCLUSION:

BAT1806/BIIB800 and TCZ were highly similar for all critical quality attributes. Where differences were observed in less critical quality attributes, additional analytical assessments and clinical study results determined these to be not clinically meaningful.

213

项与托珠单抗生物类似药 (百奥泰生物) 相关的新闻（医药）

2025-04-10

·药智网

百奥泰4条ADC管线进入临床

在医药行业风起云涌的今天，百奥泰以其特色“生物类似药+创新药”双轮驱动模式，在2024年交出了一份稳健的成绩单。1总营收7.43亿元公司实现营业收入约7.43亿元人民币，同比增长5.44%。财务数据显示，百奥泰的经营活动现金流净额虽为负，但同比大幅改善，显示出公司在销售和管理上的优化成效。尽管公司尚未实现盈利，但其在研发上的持续高投入（研发费用高达7.78亿元，占营业收入的104.64%）彰显了其对创新的执着追求。2024年，百奥泰在研发领域捷报频传。公司首款国家1类创新药枸橼酸倍维巴肽注射液（商品名：贝塔宁）获得NMPA批准上市，为急性冠脉综合征患者带来了新的治疗选择。同时，公司在生物类似药领域也取得了重大突破，BAT1706（贝伐珠单抗）和BAT1806（托珠单抗）分别在欧美和巴西等多地获批，成为国产生物类似药的标杆。百奥泰还与多家国际药企达成授权合作，例如，就BAT2506（戈利木单抗）和BAT2206（乌司奴单抗）分别与STADA和Hikma达成合作，首付款及里程碑付款总额高达数亿美元，这不仅为公司带来了可观的收入，也进一步巩固了其在国际市场上的地位。另外，百奥泰目前有多个产品处于临床Ⅲ期或关键注册临床研究阶段，涵盖肿瘤、自身免疫疾病、心血管疾病等多个领域，预示着其在未来几年内有望推出更多具有竞争力的产品。24条ADC管线进入临床特别值得注意的是，百奥泰在抗体偶联药物（ADC）领域再出发。在BAT8001、BAT8003折戟后，百奥泰开发了新的ADC平台，目前已有4个ADC管线进入临床研究阶段，包括BAT8006(FRαADC)、BAT8010(HER2 ADC)、BAT8008(Trop2 ADC)和BAT8007(Nectin-4 ADC)。图1 百奥泰ADC管线图片来源：药智数据BAT8006进入卵巢癌Ⅲ期临床。该药是百奥泰旗下首个基于自研ADC新平台开发进入临床阶段的ADC，是一款靶向叶酸受体α（FRα）的ADC。BAT8006在铂耐药卵巢癌(PROC)患者中显现出优越的客观缓解率（ORR）和中位无进展生存期(mPFS)，覆盖人群广泛。项目正在启动中国Ⅲ期关键注册临床研究。2024年底向FDA递交开展国际II/Ⅲ期临床试验，已获默认许可。依据2024年ASCO报告：截至2024年5月8日，54例铂难治或铂耐药的上皮性卵巢癌、输卵管癌或原发性腹膜癌患者，不论FRα表达水平的ORR为37.0%(20/54)。在中位随访6.5个月（1.3,18.0个月）时，中位缓解持续时间(DOR)为6.3个月（1.8~16.5个月），mPFS为7.47个月（4.27~NA）。在6个月、1年时的总生存率分别为83.0%、83.0%。另外，百奥泰正在探索ADC+I/O组合疗法。BAT8006+BAT1308(FRα-ADC+PD-1)联合用药IND获得批准治疗晚期实体瘤患者。目前处于受试者招募阶段。BAT8008+BAT1308(Trop2-ADC+PD-1)联合用药IND获得批准治疗晚期实体瘤患者。目前已完成Ib期爬坡阶段，安全性良好。目前在非小细胞肺癌、三阴乳腺癌以及其他上皮来源实体瘤中开展Ⅱ期扩展研究。BAT8010+BAT1006(HER2-ADC+HER2)联合用药IND获得批准治疗局部晚期或转移性实体瘤患者。目前处于Ia爬坡阶段，将探索在乳腺癌和胃癌的疗效。3结语百奥泰通过“生物类似药+创新药”的策略，实现现金流改善。而在研产品方面，再次重仓ADC疗法，4款产品已进入临床研究阶段，未来可期。权威榜单定义行业标杆，赋能企业品牌价值！识别二维码，解锁年度惊喜！声明：本内容仅用作医药行业信息传播，不代表药智网立场。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 小月石合作、投稿 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

临床3期抗体药物偶联物ASCO会议生物类似药引进/卖出

2025-04-09

·GBIHealth

阿斯利康/第一三共Datroway在欧盟获批

药械追踪No.1 / BMS欧狄沃联合逸沃在美获批新适应证，一线治疗MSI-H/dMMR mCRC2025年4月9日，百时美施贵宝（BMS）宣布，旗下欧狄沃（纳武利尤单抗）和逸沃（伊匹木单抗）联合疗法已获美国FDA批准新适应证，用于不可切除或转移性微卫星不稳定性高（MSI-H）或错配修复缺陷（dMMR）结直肠癌（mCRC）成人和12岁及以上儿童患者的一线治疗。此前FDA已授予该申请突破性疗法认定和优先审评资格。此次批准基于CheckMate-8HW试验，该试验是迄今为止在MSI-H/dMMR mCRC患者中开展的规模最大的免疫治疗III期试验（n=839），评估了欧狄沃联合逸沃对比欧狄沃单药在所有治疗线中的疗效，以及欧狄沃联合逸沃对比研究者选择的化疗在一线治疗中的疗效。欧狄沃联合逸沃达到了双重主要终点，与所有治疗线中的欧狄沃单药以及一线化疗相比，盲态独立中心审查（BICR）评估的无进展生存期（PFS）均有所改善。->点击文末阅读原文，解锁完整双语新闻No.2 / 艾伯维乌帕替尼获欧盟批准新适应证，治疗巨细胞动脉炎2025年4月9日，艾伯维（纽交所代码：ABBV）宣布，瑞福（乌帕替尼）已获欧盟委员会（EC）批准用于治疗成人巨细胞动脉炎（GCA）。这是乌帕替尼获欧盟批准的第八项适应证，也是欧盟及冰岛、列支敦士登和挪威首次批准口服JAK抑制剂用于GCA治疗。GCA是一种自身免疫性疾病，导致颞动脉及其他颅动脉、主动脉及大中型动脉炎症。患者通常为50岁以上人群，最常见于70至80岁。乌帕替尼此次GCA适应证获批是基于关键III期SELECT-GCA试验的积极结果。该试验显示，与安慰剂联合52周糖皮质激素减量方案相比，乌帕替尼联合26周激素减量方案达到持续缓解主要终点，并显著改善关键次要终点，包括疾病复发减少、激素累积暴露量降低以及完全缓解等各项指标。->点击文末阅读原文，解锁完整双语新闻No.3 / 阿斯利康/第一三共Datroway在欧盟获批用于经治HR+/HER2-乳腺癌2025年4月9日，阿斯利康/第一三共Trop-2靶向抗体偶联药物（ADC）Datroway（Dato-Dxd）在欧盟获批，用于治疗既往接受过内分泌治疗及至少一线晚期化疗的不可切除或转移性激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性（IHC 0、IHC 1+或IHC 2+/ISH-）乳腺癌成年患者。Datroway由阿斯利康与第一三共联合开发。双方在2020年7月就Datroway达成合作，第一三共保有Datroway在日本的独家权益，并负责其全球开发的生产供应。Datroway此前已于2024年12月和2025年1月先后在日本和美国获批用于经治HR+/HER2-乳腺癌的治疗；本次获得欧盟批准基于TROPION-Breast01研究（NCT05104866）的积极结果，该研究显示相比化疗组，Dato-Dxd治疗组的无进展生存期（mPFS：6.9个月 vs 4.9个月）显著改善，总缓解率（ORR：36% vs 23%）和缓解持续时间（mDOR：6.7个月 vs 5.7个月）均有效提升。->点击文末阅读原文，解锁完整双语新闻企业动态No.1 / 百奥泰2024年财报：收入增长5.4%2025年4月8日，百奥泰（688177.SH）发布2024年公司财务业绩。报告期内，公司实现营业收入743,166,060.09元，同比增长5.44%，主要原因是格乐立（阿达木单抗）注射液持续增长，同时托珠单抗注射液新增境外供货业务，但境外合作商尚处于拓展初期，营业收入整体增额较小。截至公告日，公司已有4款产品获中国NMPA上市批准，包括：格乐立（阿达木单抗）、普贝希（贝伐珠单抗）、施瑞立（托珠单抗）和贝塔宁（枸橼酸倍维巴肽）；2款产品获美国FDA及欧洲EMA上市批准：TOFIDENCE（托珠单抗）和Avzivi（贝伐珠单抗）；1款产品获巴西ANVISA上市批准：Bevyx（贝伐珠单抗）。此外，公司BAT2206（乌司奴单抗）已向NMPA、FDA、EMA递交上市许可申请并获得受理，BAT2506（戈利木单抗）已向EMA和NMPA递交上市许可申请并获得受理，BAT2306（司库奇尤单抗）已向NMPA递交上市许可申请并获得受理；5款产品（BAT4406F，BAT3306，BAT1308，BAT8006，BAT5906）处于临床III期或关键注册临床研究阶段，公司还有多款产品处于临床研究及临床前研究阶段。->点击文末阅读原文，解锁完整双语新闻行业政策No.1 / NMPA：进一步做好《药品生产许可证》发放工作，7月1日起统一二维码管理2025年4月7日，国家药监局（NMPA）发布关于进一步做好《药品生产许可证》发放有关事项的公告，旨在通过数字化手段优化营商环境。公告要求，2025年7月1日以后发放的《药品生产许可证》，各省级局应统一以本行政区域内电子证照二维码形式管理，《药品生产许可证》正本、副本的纸质版和电子证照应分别标注二维码。药品生产许可、变更、委/受托等信息应于相关工作完成后的5个工作日内上传至国家药监局《药品生产许可证》管理模块。自2026年1月1日起，扫描上述二维码应准确显示企业基本信息、车间和生产线情况、委/受托生产情况、变更记录等正本和副本信息，并确保二维码展示信息的及时动态更新。除首次申请办理外，凡二维码扫码可展示的信息，《药品生产许可证》的正本、副本纸质版可不再重复登载、更新。对企业提出申请的，各省局应当按规定为该企业换发纸质版，同时收回旧版许可证。各级药监部门根据《药品生产许可证》正本、副本二维码封装信息开展药品审评、检查、检验等相关工作，药品上市许可持有人、药品生产企业可无需提供纸质版。->点击阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ xujingou@baidu.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

优先审批突破性疗法临床3期临床结果上市批准

2025-04-02

·PipelineReview

Organon Acquires TOFIDENCE™ (tocilizumab-bavi), a Commercialized Biosimilar to ACTEMRA® (tocilizumab) Injection, for Intravenous Infusion in the U.S.

Strengthens and expands U.S. biosimilars immunology portfolio with multi-indication arthritis treatment JERSEY CITY, NJ, USA I April 01, 2025 I Organon (NYSE: OGN), a global healthcare company with a deep expertise in biosimilars, today announced that it has acquired from Biogen Inc. (Nasdaq: BIIB) regulatory and commercial rights in the U.S. for TOFIDENCE ™ , a biosimilar to ACTEMRA ® , for intravenous infusion. TOFIDENCE, the first approved tocilizumab biosimilar entrant in the U.S. market, was launched in May 2024 and is indicated in certain patients for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19. “Biosimilars continue to be a key growth driver for Organon, and this acquisition complements our existing business, enabling us to expand our immunology portfolio,” said Kevin Ali, Organon’s Chief Executive Officer. “We believe that by leveraging our commercial expertise and market access capabilities, there is considerable growth potential for this product.” Under the terms of the agreement, Organon has acquired the regulatory and commercial rights to TOFIDENCE in the U.S., available in three vial sizes, 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL, for further dilution prior to intravenous infusion. Bio-Thera Solutions Ltd., the product developer, will maintain manufacturing rights for TOFIDENCE for the U.S. market. The agreement includes an upfront payment to Biogen, with Organon assuming the obligation to pay tiered royalty payments based on net sales and tiered annual net sales milestone payments owed by Biogen to Bio-Thera Solutions Ltd. ABOUT TOFIDENCE (tocilizumab-bavi) TOFIDENCE (tocilizumab) is a treatment developed as a biosimilar to the reference product ACTEMRA. TOFIDENCE is indicated for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and Coronavirus Disease 2019. INDICATIONS AND USAGE Rheumatoid Arthritis (RA) TOFIDENCE is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA) TOFIDENCE is indicated for the treatment of giant cell arteritis in adult patients. Polyarticular Juvenile Idiopathic Arthritis (PJIA) TOFIDENCE is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Systemic Juvenile Idiopathic Arthritis (SJIA) TOFIDENCE is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Coronavirus Disease 2019 (COVID-19) TOFIDENCE is indicated for the treatment of coronavirus disease 2019 in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Before prescribing, please read the full Prescribing Information. About Organon Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers over 70 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. Organon is also pursuing opportunities to collaborate with biopharmaceutical partners and innovators who look to commercialize their products by leveraging Organon’s scale and agile presence in fast growing international markets. Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. For more information, visit http://www.organon.com and connect with us on LinkedIn , Instagram , X (formerly known as Twitter) and Facebook . SOURCE: Organon

上市批准并购引进/卖出生物类似药

100 项与托珠单抗生物类似药 (百奥泰生物) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AC07	-

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
新型冠状病毒感染	欧盟	Biogen Netherlands BV	2024-06-20
新型冠状病毒感染	冰岛	Biogen Netherlands BV	2024-06-20
新型冠状病毒感染	列支敦士登	Biogen Netherlands BV	2024-06-20
新型冠状病毒感染	挪威	Biogen Netherlands BV	2024-06-20
少关节关节炎	欧盟	Biogen Netherlands BV	2024-06-20
少关节关节炎	冰岛	Biogen Netherlands BV	2024-06-20
少关节关节炎	列支敦士登	Biogen Netherlands BV	2024-06-20
少关节关节炎	挪威	Biogen Netherlands BV	2024-06-20
多关节型幼年特发性关节炎	美国	Biogen MA, Inc.	2023-09-29
细胞因子释放综合征	中国	百奥泰生物制药股份有限公司	2023-01-16
类风湿关节炎	中国	百奥泰生物制药股份有限公司	2023-01-16
全身型幼年特发性关节炎	中国	百奥泰生物制药股份有限公司	2023-01-16

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
幼年特发性关节炎	申请上市	美国	百奥泰生物制药股份有限公司	2022-12-09

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


NCT03830203 \| EUCTR2018-002202-31-BG (Pubmed \| Arthritis Res Ther)	临床3期	类风湿关节炎	621	TCZ	獵鬱淵夢齋蓋繭壓窪壓(夢觸艱膚鏇廠襯範積鹽) = 鑰壓製顧艱網觸夢鹹網鑰膚淵憲繭壓夢範襯窪 (鬱鹹遞齋齋鬱製鑰廠襯 )	积极	2024-09-07
				TCZ to BAT1806/BIIB800	獵鬱淵夢齋蓋繭壓窪壓(夢觸艱膚鏇廠襯範積鹽) = 鑰夢衊壓獵構築鏇鏇鏇鑰膚淵憲繭壓夢範襯窪 (鬱鹹遞齋齋鬱製鑰廠襯 )
NCT03830203 \| EUCTR2018-002202-31-BG (Pubmed 1 \| Pubmed 2 \| Lancet Rheumatol) 人工标引	临床3期	类风湿关节炎	621	BAT1806	觸壓壓觸鏇構衊構衊選(餘積積膚積壓築製壓齋) = 襯膚艱夢壓範齋醖選艱鬱繭鬱選顧襯夢願鹹憲 (壓顧網蓋願觸鹹醖繭夢 ) 更多	相似	2024-01-01
				tocilizumab	觸壓壓觸鏇構衊構衊選(餘積積膚積壓築製壓齋) = 觸積膚積網網製憲鏇淵鬱繭鬱選顧襯夢願鹹憲 (壓顧網蓋願觸鹹醖繭夢 ) 更多
CTR20180039 \| NCT03606876 (Pubmed \| Front Pharmacol) 人工标引	临床1期	-	138	BAT1806	積襯艱淵製觸鹽顧鑰選(膚鑰構夢築鑰獵鹹鑰製) = similar in all three groups: BAT1806 (n = 45), RoActemra-EU (n = 42), and Actemra-US (n = 42). The 90% confidence intervals (CIs) for the ratios of C max , AUC0-t and AUC0-∞ were 86.90-104.41% for BAT1806 vs. RoActemra-EU, 91.70-106.15% for BAT1806 vs Actemra-US, and 90.04-105.53% for Actemra-US vs RoActemra-EU. For all comparisons, the 90% CIs for the C max , AUC0-t , and AUC0-∞ were within the predefined bioequivalence limit of 80.00-125.00%. 顧鑰艱衊願鹽壓蓋窪願 (範鏇衊製簾鏇夢餘糧鹹 )	相似	2020-01-01
				RoActemra-EU