A Randomized, Double-blind, Parallel-group, Multi-center Phase 3 Comparative Study Investigating Efficacy and Safety of LA-EP2006 and Neulasta® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy

The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

开始日期2012-06-01

申办/合作机构

山德士有限公司

[+1]

NCT01516736

/ Completed临床3期

Pivotal Study in Breast Cancer Patients Investigating Efficacy and Safety of LA-EP2006 and Neulasta®

开始日期2012-03-01

申办/合作机构

Sandoz Group AG

[+1]

100 项与培非格司亭生物类似药(Clariant AG) 相关的临床结果

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100 项与培非格司亭生物类似药(Clariant AG) 相关的转化医学

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100 项与培非格司亭生物类似药(Clariant AG) 相关的专利（医药）

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项与培非格司亭生物类似药(Clariant AG) 相关的文献（医药）

2023-12-01·Drug Safety

Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch

Review

作者: Kalsekar, Sameer ; Anjaneya, Pradeep ; Sagi, Sreedhar ; Kottke, Andrea ; Cohen, Hillel P

BACKGROUNDBiosimilars are additional treatment options that are approved based on robust analytical and clinical comparisons with their reference biologic. At the time of initial approval, the full safety profile of a biosimilar is inferred from the reference biologic. Nonetheless, there are still lingering concerns related to the long-term safety of biosimilars. Therefore, we reviewed the post-approval pharmacovigilance data for eight marketed biosimilars from one Marketing Authorization Holder (MAH) to summarize their safety experience in a real-world setting for up to 18 years since their first biosimilar launch.METHODSPost-approval cumulative patient exposure and safety experience for eight Sandoz biosimilars [adalimumab (Hyrimoz^®), epoetin alfa (Binocrit^®), etanercept (Erelzi^®), filgrastim (Zarzio^®), infliximab (Zessly^®), pegfilgrastim (Ziextenzo^®), rituximab (Rixathon^®), and somatropin (Omnitrope^®)] was summarized based on the available pharmacovigilance data from Periodic Safety Update Reports (PSURs) and the corresponding health authority-authored PSUR assessment reports, where available, as of 31 January 2023. Exposure to all biosimilars was calculated in patient treatment days (PTD) except for rituximab, which was expressed in number of patient doses (PD).RESULTSThe combined post-approval cumulative exposure to seven out of the eight marketed Sandoz biosimilars was more than 1.3 billion PTD and for rituximab more than 1.8 million PD. Overall, a critical analysis of the cumulative safety data of all eight Sandoz biosimilar PSURs concluded that the overall benefit-risk profile of each remains favorable and is consistent with the respective reference biologics.CONCLUSIONSThis is one of the largest reviews of post-approval biosimilar pharmacovigilance data to date by one MAH. The real-world experience of all eight marketed Sandoz biosimilars for up to 18 years demonstrates that Sandoz biosimilars can be used as safely as their respective reference biologics. Therefore, patients and healthcare providers can be confident in the clinical benefit and safety of Sandoz biosimilars. It is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The long-term safety of biosimilars demonstrated here provides strong support for the concept of biosimilarity.

2023-08-01·Annals of Hematology

Correction to: Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high‑dose melphalan and autologous stem cell transplantation

作者: Naso, Virginia ; Pugliese, Marta ; Verduci, Chiara ; Tripepi, Giovanni ; Porto, Gaetana ; Ieracitano, Maria Consuelo ; Moscato, Tiziana ; Gori, Mercedes ; Canale, Filippo Antonio ; Imbalzano, Lucrezia ; Alati, Caterina ; Altomonte, Maria ; Pitino, Annalisa ; Pellicano, Maria ; Irrera, Giuseppe ; Ferreri, Anna ; Santoro, Ludovica ; Loteta, Barbara ; Cuzzocrea, Amelia ; Morabito, Antonella ; Martino, Massimo ; Console, Giuseppe ; Florenzano, Maria Teresa

Multiple myeloma (MM) is the main indication for autologous stem cell transplantation (ASCT).Novel supportive therapies (e.g., granulocyte colony-stimulating factor) have significantly improved post-ASCT-related mortality; however, data on biosimilar pegfilgrastim-bmez (BIO/PEG) in this setting is lacking.This prospective cohort study compared Italian patients with MM who received BIO/PEG post-ASCT with data collected retrospectively from historical control groups from the same center who received either filgrastim-sndz (BIO/G-CSF) or pegfilgrastim (PEG; originator).The primary endpoint was time to neutrophil engraftment (three consecutive days with an absolute neutrophil count ≥ 0.5 x 109/L).Secondary endpoints included incidence and duration of febrile neutropenia (FN).Of the 231 patients included, 73 were treated with PEG, 102 with BIO/G-CSF, and 56 with BIO/PEG.Median age was 60 years and 57.1% were male.Neutrophil engraftment was reached after a median of 10 days in the BIO/PEG and PEG groups and 11 days in the BIO/G-CSF group.Among patients who achieved neutrophil engraftment earlier than this (i.e., day 9), 58% (29/50) were on PEG; of those who achieved it later (i.e., day 11), 80.8% (59/73) were on BIO/G-CSF.FN incidence was higher with BIO/G-CSF (61.4%) vs. PEG (52.1%) or BIO/PEG (37.5%) (p = 0.02 among groups).Patients on BIO/PEG had less frequent grade 2-3 diarrhea (5.5%) compared with BIO/G-CSF (22.5%) or PEG (21.9%); grade 2-3 mucositis was most frequent in the BIO/G-CSF group.In conclusion, pegfilgrastim and its biosimilar displayed an advantageous efficacy and safety profile compared with biosimilar filgrastim in patients with MM post-ASCT.

2023-07-01·Annals of Hematology

Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high-dose melphalan and autologous stem cell transplantation

Article

作者: Naso, Virginia ; Pugliese, Marta ; Verduci, Chiara ; Tripepi, Giovanni ; Porto, Gaetana ; Ieracitano, Maria Consuelo ; Moscato, Tiziana ; Gori, Mercedes ; Canale, Filippo Antonio ; Imbalzano, Lucrezia ; Alati, Caterina ; Altomonte, Maria ; Pellicano, Maria ; Pitino, Annalisa ; Irrera, Giuseppe ; Ferreri, Anna ; Santoro, Ludovica ; Loteta, Barbara ; Cuzzocrea, Amelia ; Morabito, Antonella ; Martino, Massimo ; Console, Giuseppe ; Florenzano, Maria Teresa

AbstractMultiple myeloma (MM) is the main indication for autologous stem cell transplantation (ASCT). Novel supportive therapies (e.g., granulocyte colony-stimulating factor) have significantly improved post-ASCT-related mortality; however, data on biosimilar pegfilgrastim-bmez (BIO/PEG) in this setting is lacking. This prospective cohort study compared Italian patients with MM who received BIO/PEG post-ASCT with data collected retrospectively from historical control groups from the same center who received either filgrastim-sndz (BIO/G-CSF) or pegfilgrastim (PEG; originator). The primary endpoint was time to neutrophil engraftment (three consecutive days with an absolute neutrophil count ≥ 0.5 × 109/L). Secondary endpoints included incidence and duration of febrile neutropenia (FN). Of the 231 patients included, 73 were treated with PEG, 102 with BIO/G-CSF, and 56 with BIO/PEG. Median age was 60 years and 57.1% were male. Neutrophil engraftment was reached after a median of 10 days in the BIO/PEG and PEG groups and 11 days in the BIO/G-CSF group. Among patients who achieved neutrophil engraftment earlier than this (i.e., day 9), 58% (29/50) were on PEG; of those who achieved it later (i.e., day 11), 80.8% (59/73) were on BIO/G-CSF. FN incidence was higher with BIO/G-CSF (61.4%) versus PEG (52.1%) or BIO/PEG (37.5%) (p = 0.02 among groups). Patients on BIO/PEG had less frequent grade 2–3 diarrhea (5.5%) compared with BIO/G-CSF (22.5%) or PEG (21.9%); grade 2–3 mucositis was most frequent in the BIO/G-CSF group. In conclusion, pegfilgrastim and its biosimilar displayed an advantageous efficacy and safety profile compared with biosimilar filgrastim in patients with MM post-ASCT.

项与培非格司亭生物类似药(Clariant AG) 相关的新闻（医药）

2024-02-13

·Business Wire

Injectable Hematology Growth Factors Report 2024 - Evolution in Therapeutic Care - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Injectable Hematology Growth Factors Report" has been added to ResearchAndMarkets.com's offering. This report is a comprehensive evaluation and analysis of the technology, products, and participants providing the driving force behind this evolving segment of the healthcare sector. The study is designed to provide drug company decision-makers, drug delivery developers, device designers, healthcare marketers, and supply chain participants with a detailed understanding of the economics, technologies, and opportunities for injection devices designed for patient self-administration. Provider organization business managers, healthcare administrators, and investors will also benefit from this study. Evolution in Therapeutic Care Several recombinant hematologic growth factors or agonists for their receptors have been produced that are useful in treating anemia, neutropenia, and thrombocytopenia, particularly in patients with end-stage renal disease or aplastic anemia or who have received cancer chemotherapy or a hematopoietic cell transplant. The shift in as-supplied packaging from single and multi-use vials to prefilled injection devices will accelerate over the next five years as drug developers move to empower an increasing number of chronically ill patients. The powerful physiological effects of antibodies, hormones, and other biological drugs also increase the need for safety and compliance. What You Will Learn Provides detailed analysis of injectable hematology growth factors delivery and device strategies, and product development factors. Assesses key markets, market dynamics, and market demographics. Analyzes therapeutic demand drivers and evaluates injectable drug products in a number of key therapeutic segments. Provides market data and forecasts. Profiles market sector participants, their product development activities, business strategies, and corporate alliances and affiliations Assesses the importance of alliances and partnerships on drug product commercialization. Evaluates the impact of economic, technology, and regulatory factors Key Topics Covered: Hematology Market Dynamics Competitive Factors Proliferation of Biological Drugs Product Manufacturers Hematology Growth Factors Devices for Administering Injectable Growth Factors Device Selection - Stability and Material Issues Competitive Landscape Prefilled Syringes Pen Injectors Dual Chamber Pens Emerging Devices Injectable Hematology Growth Factors - Product Assessment Abseamed Accofil Aranesp Binocrit Biograstim Biopoin Epoetin Alfa Hexal Eporatio Filgrastim Hexal Fulphila Granix Grastofil Mircera NeoRecormon Neulasta Neupogen Nivestim Ratiograstim Retacrit Rolvedon Silapo Tevagrastim Udenyca (Coherus BioSciences) Zarzio Ziextenzo Market Assessment Anemia Hematopoietic Stem Cell Transplant Advanced Kidney Disease Neutropenia Predonation of Autologous Blood Company Profiles Companies Mentioned AbZ-Pharma Accord Healthcare Amgen Genentech Hexal AG Medice Arzneimittel Mylan International Novartis Pfizer Ratiopharm Rentscler Biotechnologie Roche Sandoz Stada Arzneimittel AG Teva Pharmaceuticals For more information about this report visit https://www.researchandmarkets.com/r/bktosb About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

ASH会议

2024-02-09

·PRNewswire

Injectable Hematology Growth Factors Report: Shift in As-Supplied Packaging from Single and Multi-use Vials to Prefilled Injection Devices will Accelerate over the Next Five Years

DUBLIN, Feb. 9, 2024 /PRNewswire/ -- The "Injectable Hematology Growth Factors Report" has been added to ResearchAndMarkets.com's offering. Understanding the rapidly advancing sector of injectable hematology growth factors is crucial for stakeholders in the healthcare industry. The latest comprehensive report evaluates the intersection of technology, products, and key players that are shaping this dynamic segment, with particular emphasis on devices designed for patient self-administration. The study presents an in-depth examination of the evolving therapeutic care landscape, highlighting significant developments in the treatment of conditions such as anemia, neutropenia, and thrombocytopenia. It analyzes the shift from traditional vials to prefilled injection devices, a trend that is likely to gain momentum over the following five years, emphasizing the market forces driving this change. Key Highlights from the Report: An in-depth analysis of device strategies and product development factors influencing the injectable hematology growth factors delivery systems. Insight into market dynamics and demographics, underpinning industry growth. An evaluation of therapeutic demand drivers across pivotal segments in healthcare. Comprehensive market data and forecast trends to inform strategic decisions. Profiles of sector participants including business strategies and corporate associations. An assessment of how alliances and partnerships affect the commercialization of drug products. Insights into the economic, technological, and regulatory factors impacting the market. Healthcare administrators, investors, and other stakeholders will benefit from this study's findings that not only chart current market conditions but also project future industry directions. It serves as a critical resource for decision-makers aiming to understand and capitalize on the opportunities presented within this segment. The report's findings are pivotal for a broad spectrum of healthcare professionals, including pharmaceutical decision-makers, device developers, healthcare marketers, and supply chain entities. It is particularly geared towards empowering chronically ill patients and enhancing safety protocols through revolutionary drug delivery methods. Stakeholders are poised to gain substantial insights into the strategies propelling the adoption of injectable hematologic treatments, facilitating informed decisions that align with the compelling trends of self-administered therapeutic care. Discover the Future of Injectable Hematology Treatments As the healthcare industry continues its inexorable march towards more patient-centric and self-managed treatment options, understanding the nuances and intricacies of injectable hematology growth factor treatments becomes ever more critical. The recent report provides these vital insights, demarking a clear view of the path forward. Stay informed on the latest in healthcare advancements and market opportunities. For further information and to explore the depth of this report, interested parties are encouraged to delve into the comprehensive analysis that awaits them. Key Topics Covered: Hematology Market Dynamics Competitive Factors Proliferation of Biological Drugs Product Manufacturers Hematology Growth Factors Devices for Administering Injectable Growth Factors Device Selection - Stability and Material Issues Competitive Landscape Prefilled Syringes Pen Injectors Dual Chamber Pens Emerging Devices Injectable Hematology Growth Factors - Product Assessment Abseamed Accofil Aranesp Binocrit Biograstim Biopoin Epoetin Alfa Hexal Eporatio Filgrastim Hexal Fulphila Granix Grastofil Mircera NeoRecormon Neulasta Neupogen Nivestim Ratiograstim Retacrit Rolvedon Silapo Tevagrastim Udenyca (Coherus BioSciences) Zarzio Ziextenzo Market Assessment Anemia Hematopoietic Stem Cell Transplant Advanced Kidney Disease Neutropenia Predonation of Autologous Blood Company Profiles Companies Mentioned AbZ-Pharma Accord Healthcare Amgen Genentech Hexal AG Medice Arzneimittel Mylan International Novartis Pfizer Ratiopharm Rentscler Biotechnologie Roche Sandoz Stada Arzneimittel AG Teva Pharmaceuticals For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

ASH会议

2023-12-05

·赛柏蓝

突发｜这家老牌药企整体出售

山德士中国100%股份被收购，员工和管线业务将并入另一家跨国药企。 017.17亿元山德士中国100%股权被收购关于山德士的上一个大新闻在今年10月，它正式从诺华分拆出来，在瑞士证券交易所独立上市。欧洲最大的仿制药企业就此诞生，如今看来，它的目标是进一步聚焦，既包括管线，也包括主要投入的市场。12月4日，总部位于南非的跨国药企爱施健（Aspen）宣布其全资子公司Aspen Global Incorporated（AGI）将以9260万欧元（按当前汇率折合人民币约7.17亿元）收购山德士在中国的业务，即山德士中国100%股份。爱施健将获得目前正由山德士中国商业化的产品管线相关的商业化权利和知识产权，以及短期至中期内将要上市的管线产品相关权利，交易金额中有1850万欧元将取决于相关产品的潜在商业表现。涉及的具体药品包括合成激素注射药物醋酸奥曲肽、骨质疏松药物密固达（唑来膦酸注射液）、真菌感染治疗药物伏立康唑等。据医药代表公众号消息，除隶属于全球开发和技术运营的员工外，山德士中国的员工将在交易交割完成后并入爱施健，交接后的薪酬福利预计基本保持相当。值得注意的是，这并非一次单向收购，山德士与爱施健的另一笔交易也在进行中。据悉，山德士将支付5550万欧元（按当前汇率折合人民币约4.3亿元），获得爱施健目前在欧洲销售的四种麻醉产品权益，在截至今年6月的财政年度内，这些药品为爱施健带来了2.8亿南非兰特（1489万美元）的收入。换句话说，山德士将中国区业务出售给爱施健的同时，买下了爱施健在欧洲市场的四种麻醉产品权益。对双方而言，这次交易的重点都是“聚焦”，也是其基于各自优势市场而做出的互换交易。此前，这两家公司已有过相关交易。2019年，山德士以高达4亿欧元的价格收购爱施健的日本业务，通过该交易获得了约20种非专利药物，其中大多数是麻醉剂和专业品牌，这扩大了山德士在日本医院渠道的覆盖范围，强化了其仿制药领域布局。山德士自诺华分拆出来独立上市后，成为欧洲最大的仿制药企，目前看来，其计划更聚焦于欧洲市场。02撤管线、退市……跨国企业忙“聚焦”不久前从诺华分拆出来时，有评论认为，山德士从此可以在决策和资源配置上更加灵活和高效，不受诺华整体战略的约束，便于往“细分市场的领导者”方向发展。推出新的生物类似药是欧洲最大仿制药企山德士接下来的重要方向，尤其在欧洲和美国市场。生物类似药研发复杂，仿制难度大，其价格和利润都比化学仿制药高很多。在众多仿制药巨头中，山德士最早布局生物类似药，其非格司亭生物类似药是美国的第一款生物类似药，于2015年上市。山德士招股书中提到的四款关键的生物类似药图源：动脉网而总部在南非的爱施健，几年来一直将中国市场作为重点发展目标。2018年，爱施健CEO Stephen Saad就曾指出，在其完成全球布局调整后，中国将超越南非成为其全球最大的市场。在最近的公司发布会上，Stephen Saad表示：“山德士的产品组合、产品线、完善的基础设施和经验丰富的团队，将扩大爱施健在世界第二大制药市场的足迹和能力，并进一步加强我们在中国未来增长的基础。”此举预计将使爱施健的年销售额增加约18亿南非兰特（合9589万美元）。爱施健中国主营麻醉类药物和抗血栓类药物在中国大陆的市场推广、临床支持等相关服务，业务覆盖全国31个省份的3000多家医院。自2015年在中国建立公司后，爱施健相继收购了GSK的抗血栓药物和阿斯利康的麻醉药组合。此外，该公司还涉及免疫抑制剂、抗肿瘤药品、生殖系统疾病药物和内分泌系统疾病药物。今年，不少跨国药企都发生了人员、部门架构到研发管线的巨大变化。其关键目标，也是“更加聚焦”。诺华将主营仿制药的山德士分拆出去，专注创新药，即是其中一个典型案例。其中，十余家大型跨国药企公布了多起精简计划，近50条管线被削减。此前，武田在三季报中公布了4条需被精简的管线，覆盖肺癌、阿尔茨海默氏症等疾病治疗领域，还涉及一款已上市产品，即因III期临床确证性研究未达主要终点等原因而启动主动退市的琥珀酸莫博赛替尼（商品名：安卫力/Exkivity）。罗氏的三季报也显示，其有四条产品研发管线将被精简，其中一项已进入III期研究、两项已进入II期、一项处于I期，覆盖多发性骨髓瘤、糖尿病视网膜病变、精神分裂症等疾病治疗领域。随着市场环境变化，业务遍布全球的大型药企更需要对非核心产品管线进行终止、剥离，同时优化人员架构，以降本增效，实现新增长。这次山德士与爱施健的交易，还显示了另一种方向：更专注于某个特定市场。END作者 | 长风陈芋来源 | 赛柏蓝赛柏蓝药械交流群扫描下方二维码加入医药代理商转型交流群扫描下方二维码加入

并购生物类似药专利到期

100 项与培非格司亭生物类似药(Clariant AG) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L03AA13	DB00019

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
化疗引起的发热性中性粒细胞减少症	美国	Sandoz, Inc.	2019-11-04
粒细胞减少性发热	挪威	Sandoz GmbH	2018-11-22
粒细胞减少性发热	冰岛	Sandoz GmbH	2018-11-22
粒细胞减少性发热	欧盟	Sandoz GmbH	2018-11-22
粒细胞减少性发热	列支敦士登	Sandoz GmbH	2018-11-22
中性粒细胞减少	列支敦士登	Sandoz GmbH	2018-11-22
中性粒细胞减少	冰岛	Sandoz GmbH	2018-11-22
中性粒细胞减少	欧盟	Sandoz GmbH	2018-11-22
中性粒细胞减少	挪威	Sandoz GmbH	2018-11-22

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
化疗引起的发热性中性粒细胞减少症	临床3期	印度	Sandoz GmbH	2012-03-01
化疗引起的发热性中性粒细胞减少症	临床3期	马来西亚	Sandoz GmbH	2012-03-01
早期乳腺癌	临床3期	马来西亚	Sandoz GmbH	2012-03-01
早期乳腺癌	临床3期	波多黎各	Sandoz GmbH	2012-03-01
早期乳腺癌	临床3期	印度	Sandoz GmbH	2012-03-01
早期乳腺癌	临床3期	美国	Sandoz GmbH	2012-03-01
早期乳腺癌	临床3期	俄罗斯	Sandoz GmbH	2012-03-01
早期乳腺癌	临床3期	西班牙	Sandoz GmbH	2012-03-01
早期乳腺癌	临床3期	智利	Sandoz GmbH	2012-03-01
早期乳腺癌	临床3期	阿根廷	Sandoz GmbH	2012-03-01

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分期

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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


P3-14-10 (SABCS2018)	N/A	-	169	LA-EP2006	網構餘獵簾鹽鬱餘願製(淵淵鹹衊積觸範窪鏇選) = 壓糧壓憲廠築壓齋鹽網繭醖廠醖選鏇積簾憲醖 (鹹選鹹觸壓餘鹽醖顧壓, 1.1435 ~ 1.2328) 更多	积极	2018-02-15
				Reference Pegfilgrastim	網構餘獵簾鹽鬱餘願製(淵淵鹹衊積觸範窪鏇選) = 齋膚選鬱觸鑰製範觸糧繭醖廠醖選鏇積簾憲醖 (鹹選鹹觸壓餘鹽醖顧壓 ) 更多
NCT01516736 (PROTECT-2 \| PROTECT2, CTgov)	临床3期	化疗引起的发热性中性粒细胞减少症 \| 乳腺癌 \| 早期乳腺癌	308	LA-EP2006 (LA-EP2006)	鬱製衊鏇憲憲鹹夢夢窪(鹹鹽顧衊獵鹽製構製築) = 齋簾膚簾憲憲製衊襯遞鏇遞壓繭餘積襯糧餘餘 (遞夢鏇醖願窪衊鹹蓋蓋, 膚觸鏇鹹衊顧鏇簾夢齋 ~ 鹹鏇網餘鑰積顧製艱艱) 更多	-	2017-06-28
				Neulasta® (Neulasta®)	鬱製衊鏇憲憲鹹夢夢窪(鹹鹽顧衊獵鹽製構製築) = 齋壓顧淵簾蓋夢鹽衊艱鏇遞壓繭餘積襯糧餘餘 (遞夢鏇醖願窪衊鹹蓋蓋, 製鬱鹹窪憲鏇醖憲憲憲 ~ 衊構鏇衊獵廠願鬱範網) 更多
NCT01735175 (PROTECT-1, CTgov)	临床3期	化疗引起的发热性中性粒细胞减少症 \| 并发症 \| 乳腺癌 \| 化疗引起的中毒	316	LA-EP2006 (LA-EP2006)	淵衊顧簾醖網艱積齋觸(壓艱製觸鑰積鹽願餘襯) = 觸遞蓋衊齋繭遞觸蓋壓夢膚繭衊鏇鹽鏇鏇築醖 (餘獵選選願壓觸範積醖, 繭醖構鬱憲糧蓋鏇艱願 ~ 積廠齋範顧壓築窪網製) 更多	-	2017-06-15
				Neulasta® (Neulasta®)	淵衊顧簾醖網艱積齋觸(壓艱製觸鑰積鹽願餘襯) = 鬱蓋糧齋淵顧憲廠製膚夢膚繭衊鏇鹽鏇鏇築醖 (餘獵選選願壓觸範積醖, 繭蓋蓋鬱憲窪餘鹹選遞 ~ 觸壓糧膚餘獵壓衊蓋夢) 更多
PROTECT1 and 2 (SABCS2017)	临床3期	乳腺癌辅助	624	LA-EP2006	(鑰艱範憲築餘繭鏇襯膚) = 製糧蓋獵衊窪鏇衊築範選憲壓觸鬱壓糧構膚製 (範夢窪鏇繭簾構壓繭廠, -0.19 ~ 0.11) 更多	积极	2017-02-15
				Reference Pegfilgrastim	鹽構襯鏇淵襯淵鹽襯艱(構鏇淵衊選壓遞蓋醖窪) = 糧膚鹽製遞壓衊蓋範壓鹹願範齋廠齋廠廠鬱廠 (夢襯膚齋齋餘憲蓋觸齋 ) 更多
NCT01516736 (PROTECT-2, Pubmed \| Oncologist) 人工标引	临床3期	中性粒细胞减少 \| 乳腺癌辅助 \| 新辅助	308	LA-EP2006	(膚膚範構壓簾憲醖餘窪) = 艱衊鑰遞廠淵遞淵憲壓膚廠願淵製襯窪醖憲選 (獵獵淵選醖製膚構鹹觸, 1.13)	相似	2016-07-01
				Pegfilgrastim	(膚膚範構壓簾憲醖餘窪) = 遞襯選淵範選繭餘衊鬱膚廠願淵製襯窪醖憲選 (獵獵淵選醖製膚構鹹觸, 0.98)
NCT01735175 (PROTECT-1, Pubmed \| Ann Oncol \| Future Oncol) 人工标引	临床3期	乳腺癌	316	LA-EP2006	(艱糧觸糧觸夢糧製觸鑰): difference = 0.07 (90% CI, -0.09 ~ 0.23)	相似	2016-06-01
				pegfilgrastim
EUCTR2012-002039-28-ES \| EUCTR2011-004532-58-BG (ASCO2016)	临床3期	乳腺癌辅助	624	LA-EP2006	(獵齋糧簾窪築製襯製衊) = 壓觸壓廠網糧願艱繭醖積壓網選鹽選鏇鏇襯膚 (積醖夢積製鑰築鏇衊顧 ) 更多	积极	2016-05-20
				Reference pegfilgrastim	(獵齋糧簾窪築製襯製衊) = 鏇選顧壓艱糧獵鬱鹹鹽積壓網選鹽選鏇鏇襯膚 (積醖夢積製鑰築鏇衊顧 ) 更多