A Randomized, Double-blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

The objective of the current study is to assess the immunogenicity and safety of transitioning subjects with RA to DRL_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab.
The primary objective of this study is to assess the immunogenicity of transitioning subjects with RA to DRL_RI (biosimilar rituximab) from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab
To assess the safety of transitioning subjects with RA to DRL_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab.

开始日期2020-04-08

申办/合作机构

Dr. Reddy's Laboratories Ltd.

NCT03976102

/ Completed临床3期

A Double-blind, Parallel-group, Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in Subjects With Previously Untreated (CD)20-Positive LTB Follicular Lymphoma

The primary objective of the current study is to demonstrate the equivalent efficacy of rituximab (DRL_RI) and MabThera® in subjects with Low Tumor Burden Follicular Lymphoma (LTB-FL).
Also evaluated by Pharmacokinetic, safety, and immunogenicity assessment between a proposed biosimilar (DRL_RI) and the RMP, as an component of clinical study program, and collectively providing the evidence of biosimilarity.
The study will compare the safety and efficacy of DRL_RI vs MabThera in patients with Low Tumor Burden Follicular Lymphoma (LTB-FL). The primary objective is to establish comparative efficacy as measured by ORR up to week 28

开始日期2019-05-15

申办/合作机构

Dr. Reddy's Laboratories Ltd.

NCT02296775

/ Completed临床1/2期

Comparative Pharmacokinetic, Pharmacodynamic, Safety and Efficacy Study of Three Anti-CD20 Monoclonal Antibodies in Patients With Moderate to Severe Rheumatoid Arthritis

This study will compare the plasma pharmacokinetic profile and the change in disease activity score in patients with active rheumatoid arthritis following treatment with two 1000 mg doses of DRL_RI or one of two sources of rituximab (Rituxan® or MabThera®). Patients will also be monitored for safety, B cell depletion and recovery, and for the development of immune responses to the administered study drugs

开始日期2014-11-01

申办/合作机构

Dr. Reddy's Laboratories Ltd.

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项与利妥昔单抗生物类似药(Dr. Reddy’s Laboratories) 相关的文献（医药）

2025-01-01·Therapeutic Advances in Medical Oncology

Efficacy and safety of rituximab biosimilar (DRL_RI) versus MabThera ^® in low-tumor-burden follicular lymphoma: the FLINTER study

Article

作者: Ramos, Ana Oliveira ; Kim, Jin Seok ; Reddy, Pramod ; Maharaj, Narendra ; Belada, David ; Eswaraiah, Anand ; Uppada, Dharma Rao ; Kakkattu, Ranjith ; Kalenik, Volha A. ; Baranau, Yauheni V.

Background and objectives::

This phase III study (RI-01-006; FLINTER) was conducted to demonstrate equivalent efficacy of DRL_RI to EU-approved rituximab (MabThera ® ) in patients with previously untreated Stage II–IV, CD20-positive, low-tumor-burden follicular lymphoma (LTB-FL). This study also evaluated safety, immunogenicity, rituximab concentrations, and pharmacodynamics (PD) of DRL_RI compared with MabThera.

Design and methods::

Previously untreated, stage II–IV, CD20-positive LTB-FL patients ( N = 317) were randomized (1:1) to receive DRL_RI ( n = 162) or MabThera ( n = 155) as intravenous infusions of 375 mg/m² weekly for 4 weeks (induction period), and thereafter every 8 weeks from Week 12 to Week 36 (maintenance treatment), and followed up till Week 52. The primary end point was best overall response rate (BORR) up to Week 28 based on blinded independent central review. Efficacy equivalence was demonstrated if the two-sided 90% confidence interval (CI) for BORR difference was within the prespecified equivalence margin (±17%). Secondary end points included objective and complete responses, duration of response, progression-free survival, overall survival, safety, immunogenicity, mean serum concentrations, and PD.

Results::

The BORR up to Week 28 was 80.2% versus 79.4% for DRL_RI versus MabThera group; with a difference of 0.89% (90% CI: −6.67 to 8.48; 95% CI: −8.05 to 9.93 within the prespecified margin). Both treatment groups were comparable for all secondary efficacy end points. Treatment-emergent adverse events were reported in 68.6% of patients; safety, immunogenicity, and mean serum concentrations were similar between groups. Peripheral B-cell counts declined below quantifiable limits in most patients, with a median time to B-cell depletion of 6.9 versus 7.0 days for DRL_RI versus MabThera.

Conclusion::

The study demonstrated efficacy equivalence of DRL_RI to MabThera; with comparable safety, immunogenicity, serum concentrations, and PD between groups.

Trial registration::

This trial was registered at ClinicalTrials.gov identifier: NCT03976102 and EudraCT (2018-004223-36).

2020-12-01·Pharmaceutical research3区 · 医学

Sedimentation Velocity Analytical Ultracentrifugation Analysis of Marketed Rituximab Drug Product Size Distribution

3区 · 医学

Article

作者: Patil, Sharadrao M ; Keire, David A ; Nguyen, John ; Chen, Kang

PURPOSE:

Analytical methods suitable for intact drug products are often necessary to evaluate the equivalence in physicochemical properties between two drug products (DP) containing the same drug substance (DS), e.g., an innovator biologic drug and its proposed biosimilar. Analytical Ultracentrifugation (AUC) is a biophysics technique applied to the analysis of size and shape of biomolecules. However, the application of AUC to formulated monoclonal antibody (mAb) DP at high concentration has not been reported.

METHODS:

A sedimentation velocity (SV) AUC procedure with a short-pathlength centerpiece was applied to two marketed rituximab DPs, Rituxan® (US) and Reditux® (India), without any buffer exchange or dilution. Detailed precision analysis was performed.

RESULTS:

Highly reproducible sedimentation coefficient values (S) and peak areas were obtained for the dominant (> 84%) monomeric rituximab peak. The minor mAb fragment peaks had large variation in both S values and peak areas (3-12%). The identification of oligomer peaks was only reproducible once the abundance was higher than 2%.

CONCLUSIONS:

SV-AUC provides an orthogonal characterization tool for protein size distribution, composition and assay, which could be informative for biosimilar drug developers who mostly only have access to formulated mAb. However, AUC needs thorough validation on its accuracy, precision and sensitivity.

2020-04-01·BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

Pharmacokinetic Similarity and Comparative Pharmacodynamics, Safety, Efficacy, and Immunogenicity of DRL_RI Versus Reference Rituximab in Biologics-Naïve Patients with Moderate-to-Severe Rheumatoid Arthritis: A Double-Blind, Randomized, Three-Arm Study

Article

作者: Kankanwadi, Suresh ; Kharkar, Sandeep ; Katta, Rahul ; Haridas, Vikram Muralidhar ; Nalawade, Ajit ; Lopez-Lazaro, Luis ; Garmish, Olena ; Zhdan, Vyacheslav ; Batra, Sonica Sachdeva

OBJECTIVES:

The aims were to demonstrate pharmacokinetic (PK) similarity between DRL_RI, a proposed rituximab biosimilar, and two reference innovator products (Rituxan^® [RTX-US] and MabThera^® [RTX-EU]) and compare their pharmacodynamics (PD), efficacy, safety, and immunogenicity in rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX)-based therapy and no prior biologic administration.

METHODS:

In this randomized, double-blind, parallel-group study, 276 patients with moderate-to-severe active RA were randomized to receive DRL_RI, RTX-US, or RTX-EU on days 1 and 15. The primary PK end points included area under the concentration-time curve from time 0 to 336 h after first infusion (AUC_{0-14 days, first infusion}), AUC from day 1 through week 16 (AUC_{0-∞, entire course}), and AUC from time 0 to time of last quantifiable concentration after the second dose (AUC_{0-t, second infusion}). Secondary end points included other PK parameters, such as maximum concentration (C_max), time to C_max after each infusion, terminal half-life, systemic clearance, and volume of distribution after the second infusion; PD parameters and efficacy until week 24; safety and immunogenicity at week 24 and 52; and B cell recovery until week 52. AUC from time 0 to time of last quantifiable concentration after the first dose and over the entire course from day 1 through week 16 (AUC_{0-t, entire course}) was analyzed as an exploratory end point.

RESULTS:

The 91% confidence intervals (CIs) of the geometric mean ratios (GMRs) for the primary end point of AUC_{0-∞, entire course} were within the bioequivalence limits of 80-125% for all comparisons: DRL_RI versus RTX-US 100.37% (92.30-109.14), DRL_RI versus RTX-EU 93.58% (85.98-101.85), and RTX-US versus RTX-EU 93.24% (85.62-101.54). PD outcomes (peripheral blood B-cell depletion and mean change in Disease Activity Score [28 joints]-C-reactive protein), efficacy, safety, and immunogenicity were also comparable between DRL_RI and the reference products.

CONCLUSION:

DRL_RI, a proposed biosimilar, demonstrated three-way PK similarity with RTX-EU and RTX-US, the reference innovator products, with comparable efficacy, PD, safety, and immunogenicity.

CLINICAL TRIALS REGISTRATION NUMBER:

ClinicalTrials.gov identifier: NCT02296775.

项与利妥昔单抗生物类似药(Dr. Reddy’s Laboratories) 相关的新闻（医药）

2026-01-15

·今日头条

印度仿制药：平价救星的光环与供应链隐忧

> 印度仿制药供应了全球约20%的药品，并占据美国近40%的仿制药进口份额。这一“世界药房”以极致的成本控制让上亿患者得以负担关键药物，但其产业光环之下，质量监管漏洞、供应链对外依赖与创新短板正构成严峻挑战。 1. 优势：成本屠夫与制度红利印度药企通过优化工艺与产业集群，能将生产成本压缩至原研药的**二十分之一**。例如，西普拉公司将一款抗艾滋病鸡尾酒疗法药物的日费用从三四十美元降至**不足一美元**。这种能力使印度供应了全球**80%**左右的抗艾滋病药物。灵活的专利制度为产业发展奠定了基础。1970年《专利法》仅保护制药工艺，2005年修法后仍保留“强制许可”等条款。2013年，印度最高法院驳回诺华公司对改进版白血病药物“格列卫”的专利申请，认定其为轻微改良，保障了仿制药供应。庞大的国际认证规模是其进入高端市场的通行证。印度已有**超过600家**企业通过美国FDA或欧洲EMA认证，另有数据显示**超过700家**制剂工厂通过FDA检查。这支撑了其出口增长，2023年印度药品出口总额约**278亿美元**，其中仿制药及相关制剂产品出口占比超过**65%**。 2. 挑战：质量地雷与供应链命门质量监管力量薄弱是产业的“阿喀琉斯之踵”。印度药品管理总局仅有**约2000名**工作人员，却要监管全国超过1万家制药厂和100万家药店。自2022年以来，多起与印度制造药品相关的死亡事件迫使政府加强审查。 > 印度《经济时报》报道，在约12000家制药企业中，8500家属于中小制药企业。其中超过60%的企业可能因无法按期升级达到药品生产质量管理规范而被迫关闭，这可能导致抗生素、降压药、镇痛药等常用药品出现短缺。国际知识产权压力持续加大。美国贸易代表办公室已连续多年将印度列入侵犯知识产权的“优先观察国”名单。2025年，印度签发了**17项**药品专利强制许可，较此前年均水平增长超过三倍，直接冲击跨国药企定价策略。原料药（API）高度依赖进口构成供应链脆弱性。印度制药业年均消耗约250万吨API，其中约**65%**的传统API和**70%**以上的关键中间体依赖从中国进口。在青霉素、头孢菌素类、阿奇霉素等关键品类上，对华依赖度高达约**90%**。创新研发能力薄弱限制产业升级。印度制药行业销售额已达**500亿美元**，但每年仅有**8%**用于抗癌产品研发，而跨国药企的研发投入比例可达**20%**。国产创新药仅能满足国内需求的约**40%**，生物制剂国产化率更低至**25%**。 3. 未来：转型之路与全球博弈面对挑战，印度政府与企业正寻求突围： - 推出“生产关联激励计划”（PLI），投入约**20.4亿美元**，旨在八年内促进53种关键原料药的本土化生产。 - 加强监管合规，印度国家药品质量管理中心联合行业协会投入超**120亿卢比**升级企业质量管理体系，合规通过率从2020年的68%提升至2024年的89%。 - 头部企业加大研发投入，尝试向生物类似药和专科药领域转型，如Dr. Reddy's Laboratories的利妥昔单抗生物类似药已在印度获批。印度仿制药的平价奇迹建立在特定政策与成本优势之上，但其可持续发展取决于能否在质量安全、供应链自主与原创研发上取得突破。对于全球公共卫生而言，一个更规范、更具韧性的印度制药业至关重要。

2024-12-07

·瑞迪博士

瑞迪博士特瑞普利单抗在印度获批上市

2024年11月28日-瑞迪博士实验室有限公司（BSE: 500124, NSE: DRREDDY），宣布特瑞普利单抗在印度上市，这是首个也是唯一一个获批用于治疗鼻咽癌的免疫肿瘤药物。 ➤ 特瑞普利单抗是唯一获得美国食品药品监督管理局（USFDA）、印度中央药品标准控制组织（DCGI）、欧洲药品管理局（EMA）、英国药品和健康产品管理局（MHRA）、中国国家药品监督管理局（NMPA）等主要监管机构批准用于治疗成人复发或转移性鼻咽癌（RM-NPC）的免疫肿瘤药物 ➤ 特瑞普利单抗与标准化疗的联合使用显示病程进展或死亡风险降低了48% ➤ 特瑞普利单抗在印度上市和在美国推出是同一年，使印度成为世界上第三个获得这种新生物实体（NBE）的国家 ➤ 特瑞普利单抗是首个从中国引进并在印度获批的NBE产品特瑞普利单抗是一种新型生物实体（NBE）。它是唯一获得美国食品药品监督管理局（USFDA）、欧洲药品管理局（EMA）、英国药品和保健品管理局（MHRA）等全球主要监管机构批准用于治疗成人复发性或转移性鼻咽癌（RM-NPC）的免疫肿瘤药物。2023年，瑞迪博士与上海君实生物科技有限公司就特瑞普利单抗签订了许可和商业化协议。根据该协议，瑞迪博士获得了在印度、南非、巴西和拉丁美洲等21个国家开发和商业化特瑞普利单抗的独家权利。此外，该协议允许瑞迪博士将许可范围扩大到澳大利亚、新西兰和其他9个国家。随着瑞迪博士上市该产品，印度成为继中国和美国之后世界上第三个获得这种PD-1抑制剂1的国家。瑞迪博士将在印度以Zytorvi®的品牌名进行市场推广。在使用特瑞普利单抗之前，印度RM-NPC的标准治疗是化疗（吉西他滨和顺铂）。特瑞普利单抗适用于成人转移性或复发局部晚期鼻咽癌（NPC）的一线治疗，与吉西他滨和顺铂联合使用，这种联合疗法显示了病程进展或死亡风险2降低了48%。此外，特瑞普利单抗已被批准作为单药疗法，用于治疗患有复发性不可切除或转移性鼻咽癌（NPC），且在接受含铂化疗期间或之后出现疾病进展的成人患者。首席执行官 M. V. Ramana先生瑞迪博士品牌市场（印度和新兴市场）首席执行官M. V. Ramana先生说到：“特瑞普利单抗的上市对于印度鼻咽癌患者来说是一个重要的里程碑。鼻咽癌是一种罕见的头颈部癌症，但晚期患者预后较差，印度是世界上疾病负担最重的五个国家之一3。作为PD-1抑制剂，特瑞普利单抗在治疗复发性不可切除或转移性鼻咽癌（RM-NPC）方面，相较于标准治疗显示出了更优越的疗效，从而满足了印度鼻咽癌患者群体中一个重要的未被满足的医疗需求。此次产品上市也是我们公司的一个重要里程碑。肿瘤学一直是我们最关注的治疗领域。我们的目标是构建一个端到端的护理生态系统——在全球多个国家提供当前标准的癌症药物，在制剂上创新，在印度和其他新兴市场针对创新分子开展战略合作，以及提供超越药物的支持，如营养建议和数字工具。我们在印度和其他新兴市场的针对癌症标准治疗的小分子和生物类似药产品组合包括Reditux™、Versavo®、Lenangio™和Hervycta™。此外，根据我们的创新计划，通过合作获得新型分子是业务关键支柱之一。因为在新兴市场，获得有意义的创新和最新标准的治疗仍然是患者面临的挑战。在我们跨职能团队不懈努力下，特瑞普利单抗与美国同年在印度上市。我们将继续努力为我们的患者和利益相关者提供服务，致力于成为他们的首选合作伙伴，并朝着到2030年服务超过15亿患者的目标迈进”。瑞迪博士与君实生物签署特瑞普利单抗许可与商业化协议鼻咽癌（NPC）是一种起源于鼻咽上皮的恶性肿瘤。根据2022年全球癌症统计（GLOBOCAN 2022）的数据，全年全球新诊断的鼻咽癌病例超过12万例。在印度，2022年新诊断的鼻咽癌病例为6,519例4。印度东北部各邦的鼻咽癌年龄调整发病率最高，其中那加兰邦的科希马（Kohima）发病率为每10万人口19.4例5。特瑞普利单抗是一种抗PD-1单克隆抗体，因其能够阻断PD-1与其配体PD-L1和PD-L2的相互作用，并增强受体内化（内吞功能）。阻断PD-1与PD-L1和PD-L2的相互作用，可提高免疫系统攻击和杀伤肿瘤细胞的能力6。参考文献： 1．Ravindranathan S,王X等人，特瑞普利单抗的特性：一种下一代抗PD-1抗体，具有强大的T细胞激活能力和在不考虑PD-L1状态的情况下增强的临床疗效。《J Immunother Cancer》2023;11(Suppl 1):A1–A1731。 2．Mai, HQ.、Chen, QY.、Chen, D.等人，特瑞普利单抗或安慰剂联合化疗作为晚期鼻咽癌的一线治疗方案：一项多中心随机3期试验。《自然医学》杂志27卷，1536-1543页（2021年）。 3. 陈玉萍、陈志明、乐秋婷、布兰查德、孙阳、马静。鼻咽癌。《柳叶刀》杂志。2019年7月6日；394(10192):64-80。 4. Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2024). 全球癌症观察：今日癌症。法国里昂：国际癌症研究机构。可从以下网址获取：https://gco.iarc.who.int/today. 5. Mailankody, Sharada 等人。“印度和南亚国家罕见癌症的流行病学——记住被遗忘的。”《柳叶刀区域健康-东南亚》12期（2023年）。 6. 陈玉萍、陈志明、乐秋婷、布兰查德、孙阳、马静。《鼻咽癌》。《柳叶刀》杂志。2019年7月6日；394(10192):64-80。前瞻性声明：本新闻稿可能包括基于管理层发表的当前观点、假设的未来预期声明及其他前瞻性声明，这些声明涉及已知或未知的风险与不确定性，可能导致实际结果、业绩或事件与该声明明示或暗示的结果、业绩或事件存在重大差异。除因上下文而具有前瞻性的声明外，“可能”、“将会”、“应该”、“预期”、“计划”、“意图”、“预计”、“相信”、“估计”、“预测”、“潜在”或“继续”等用词以及类似表述均指前瞻性声明。实际结果、业绩或事件可能与该声明中表述的结果、业绩、事件存在重大差异，原因包括但不限于：（i）一般经济状况，如金融市场表现、信用违约、货币汇率、利率、持续性水平及保险损失事件的发生频率/严重程度；（ii）死亡率与发病率的发展水平及趋势；（iii）竞争水平与一般竞争因素的变化；（iv）法律法规与中央银行和/或政府政策的变化；（v）收购或重组的影响，包括相关的整合问题；（vi）我公司业务、市场、客户、产品及服务对自然灾害、流行病、流行病或其他广泛流行疾病（包括冠状病毒（或新冠肺炎）所造成经济衰退的易感性；（vii）在我公司提交给证券交易委员会公开文件中所确定的其他风险与不确定性，包括截至2023年3月31日年度报告表20-F“风险因素”和“前瞻性声明”中列出的内容。公司没有义务更新在此包含的任何信息。 1. 本文翻译自瑞迪博士全球新闻稿，原文链接为： Dr. Reddy's press release - launch of Toripalimab in India.pdf 2. 本文旨在传递医药前沿信息，不构成对任何药物或诊疗方案的推荐或推广。 3. 如您想了解更多疾病知识或药品、诊疗相关信息，请咨询医疗卫生专业人士。关于瑞迪博士瑞迪博士实验室有限公司是一家全球性制药公司，并于纽约证券交易所（股份代号：RDY）、印度国家证券交易所（股份代号：DRREDDY）及孟买证券交易所（股份代号：500124）上市。瑞迪博士成立于1984年，其产品和服务涵盖广泛的治疗领域，涉及制药服务与活性成分(PSAI)、全球仿制药、专利产品和生物类似药。我们本着加快获得经济实惠的创新药品的承诺，不断寻求进入新的治疗领域以满足世界各地患者未被满足的用药需求，因为“健康不能等待”！

上市批准申请上市临床3期

2024-08-01

·ETPharma

Dr Reddy’s drug gets EMA CHMP approval

Hyderabad: Pharma biggie Dr Reddy’s Laboratories Ltd on Monday said the European Medicines Agency ’s (EMA) committee for medicinal products for human use (CHMP) has recommended its proposed Rituximab biosimilar candidate — Ituxredi — for the European markets . The EMA CHMP has adopted a positive opinion recommending the launch of its proposed Rituximab biosimilar Ituxredi in European markets, the Hyderabad-based company said in a regulatory filing. Dr Reddy’s Ituxredi is a generic version of Roche’s MabThera that is used for the treatment of non-Hodgkin’s lymphoma , chronic lymphocytic leukaemia , rheumatoid arthritis , Wegener’s granulomatosis, among others. The CHMP positive opinion will now be reviewed by the European Commission (EC)as part of the established approval process, and a decision on granting the marketing authorisation in EU member countries and European Economic Area (EEA) member states such as Norway, Iceland, and Liechtenstein would be taken after this, it said. Dr Reddy’s said a marketing authorisation application submission will be made separately to the UK Medicines and Healthcare products Regulatory Agency (MHRA).

上市批准

100 项与利妥昔单抗生物类似药(Dr. Reddy’s Laboratories) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC02	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
慢性淋巴细胞白血病	欧盟	Reddy Holding GmbH	2024-09-19
慢性淋巴细胞白血病	冰岛	Reddy Holding GmbH	2024-09-19
慢性淋巴细胞白血病	列支敦士登	Reddy Holding GmbH	2024-09-19
慢性淋巴细胞白血病	挪威	Reddy Holding GmbH	2024-09-19
非霍奇金淋巴瘤	印度	Dr. Reddy's Laboratories Ltd.	2007-01-01
类风湿关节炎	印度	Dr. Reddy's Laboratories Ltd.	2007-01-01

未上市

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
急性淋巴细胞白血病	申请上市	欧盟	Reddy Holding GmbH	2024-07-25
伯基特淋巴瘤	申请上市	欧盟	Reddy Holding GmbH	2024-07-25
CD20阳性弥漫性大B细胞淋巴瘤	申请上市	欧盟	Reddy Holding GmbH	2024-07-25
难治性慢性淋巴细胞白血病	申请上市	欧盟	Reddy Holding GmbH	2024-07-25
滤泡性淋巴瘤	申请上市	欧盟	Reddy Holding GmbH	2024-07-25
肉芽肿伴多血管炎	申请上市	欧盟	Reddy Holding GmbH	2024-07-25
显微镜下多血管炎	申请上市	欧盟	Reddy Holding GmbH	2024-07-25
天疱疮	申请上市	欧盟	Reddy Holding GmbH	2024-07-25
复发性慢性淋巴细胞白血病	申请上市	欧盟	Reddy Holding GmbH	2024-07-25

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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


NCT03976102 (RI-01-006; FLINTER, Pubmed \| Ther Adv Med Oncol)	临床3期	滤泡性淋巴瘤 CD20-positive	317	DRL_RI	廠鬱範壓鹽範構範獵築(範鹽蓋窪襯顧築淵衊製) = 遞壓膚憲夢齋鏇鏇廠壓餘築蓋餘繭鏇膚積選餘 (遞積構糧醖繭齋糧繭夢, -6.67 ~ 8.48)	积极	2025-01-01
				MabThera	廠鬱範壓鹽範構範獵築(範鹽蓋窪襯顧築淵衊製) = 餘築鹽築範獵糧築製簾餘築蓋餘繭鏇膚積選餘 (遞積構糧醖繭齋糧繭夢 )
NCT03976102 (RI-01-006; FLINTER \| FLINTER, CTgov)	临床3期	滤泡性淋巴瘤	317	DRL_RI (Proposed rituximab biosimilar) (Arm A: DRL_RI)	遞簾遞齋製齋鏇蓋選觸 = 餘願選選積糧鹹鹽壓襯鹹衊選顧壓鹽憲衊衊願 (齋廠選獵鏇淵築糧遞遞, 蓋觸衊鑰構艱鏇襯鑰壓 ~ 膚繭夢鬱鏇夢簾網淵襯) 更多	-	2024-01-22
				MabThera® (Arm B: MabThera®)	遞簾遞齋製齋鏇蓋選觸 = 壓願窪襯餘衊廠網網築鹹衊選顧壓鹽憲衊衊願 (齋廠選獵鏇淵築糧遞遞, 憲餘鹽衊鏇網願範餘觸 ~ 艱鏇蓋繭鏇獵廠淵獵鹹) 更多
NCT04268771 (RI-01-007, CTgov)	临床3期	类风湿关节炎	140	Experimental: Arm A: DRL_RI (Arm A: DRL_RI)	壓糧衊製願廠築鑰餘窪 = 糧簾積憲鹽鏇顧構夢築憲鑰積夢積鹹願顧鹹膚 (願遞網鑰鏇夢齋夢繭顧, 築選網餘艱積鹽範艱窪 ~ 蓋獵膚範鏇餘鏇鬱鏇築) 更多	-	2023-11-18
				Mabthera+Rituxan (Arm B: US-Rituximab or EU-Rituximab)	壓糧衊製願廠築鑰餘窪 = 選積艱醖積觸糧襯艱鑰憲鑰積夢積鹹願顧鹹膚 (願遞網鑰鏇夢齋夢繭顧, 鑰齋淵鬱築構顧鏇遞艱 ~ 網衊獵顧襯築網糧鹹鏇) 更多
NCT02296775 (CTgov)	临床1/2期	类风湿关节炎	276	Rituximab (DRL- Rituximab-DRL_RI)	夢繭網膚鹹齋簾築艱糧(夢糧築構蓋艱範築鏇簾) = 淵膚鬱構窪積蓋繭壓選觸蓋醖鏇遞蓋襯範醖鬱 (淵衊鑰糧窪製窪築遞製, 27.1) 更多	-	2020-01-13
				Rituxan (Rituxan® (US Licensed Reference Product): RP)	夢繭網膚鹹齋簾築艱糧(夢糧築構蓋艱範築鏇簾) = 壓醖顧積廠蓋壓夢齋憲觸蓋醖鏇遞蓋襯範醖鬱 (淵衊鑰糧窪製窪築遞製, 25.4) 更多