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

Sandoz Group AG

[+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]

PER-119-11

临床3期

PIVOTAL STUDY IN PATIENTS WITH BREAST CANCER TO INVESTIGATE THE EFFICACY AND SAFETY OF LA-EP2006 and NEULASTA ®

开始日期-

申办/合作机构

Sandoz GmbH

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

BACKGROUND:

Biosimilars 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.

METHODS:

Post-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).

RESULTS:

The 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.

CONCLUSIONS:

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

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

Abstract:

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 × 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）

2025-11-19

·药出海

最新：美国FDA已批准的生物类似药汇总

11月13日，美国FDA批准复宏汉霖的Poherdy（pertuzumab-dpzb）生物制品许可申请（BLA），并可与原研Perjeta（帕妥珠单抗）互换使用。Poherdy成为美国首款且唯一的Perjeta生物类似药，覆盖Perjeta在美国已获批的所有适应症，用于 HER2 阳性早期乳腺癌的新辅助/ 辅助和转移性乳腺癌治疗。据了解，帕妥珠单抗原研药于2012年6月获FDA批准上市，2024年的全球销售额约为40.279亿美元。 2025年1-11月美国FDA共批准15种生物类似药 2025年1月至11月期间，FDA批准了15个生物类似药，包括：7种地舒单抗Osvyrti and Jubereq (denosumab-desu)、Enoby and Xtrenbo (denosumab-qbde)、Aukelso and Bosaya (denosumab-kyqq)、Bildyos and Bilprevda (denosumab-nxxp)、Bomyntra and Conexxence (denosumab-bnht)、Stoboclo and Osenvelt (denosumab-bmwo)和Ospomyv and Xbryk (denosumab-dssb)；2种门冬胰岛素Kirsty (insulin aspart-xjhz)和Merilog (insulin aspart-szjj)；帕妥珠单抗Poherdy (pertuzumab-dpzb)；阿柏西普Eydenzelt (aflibercept-boav)；乌司奴单抗Starjemza (ustekinumab-hmny)；贝伐珠单抗Jobevne (bevacizumab-nwgd) ；奥马珠单抗Omlyclo (omalizumab-igec)；托珠单抗Avtozma (tocilizumab-anoh)。盘点：美国FDA已批准的生物类似药截止2025年11月19日，美国FDA共批准78个生物类似药，涵盖20种生物药，包括多款重磅药物，如2024年销售额达103.61亿美元的乌司奴单抗(ustekinumab)、96.45亿美元的阿柏西普(aflibercept)、89.93亿美元的阿达木单抗(adalimumab)等。靶点包括TNF-α、RANKL、IL-12/IL-23、VEGF-A、HER2、TNF-α、IL-6RA、CD20、C5、CD49d、IgE等。其中，FDA于2015年3月批准首个生物类似药 Zarxio（filgrastim-sndz），该药由 Sandoz 公司生产，是 Neupogen（filgrastim）的生物类似药。按照生物类似药获批数量排序，阿达木单抗以10个生物类似药数量稳居第一，其次是地舒单抗和乌司奴单抗各8个。紧跟其后是贝伐珠单抗、阿柏西普、曲妥珠单抗、培非格司亭各6个。根据IQVIA报告，2025至2034年间，将有118种价值2340亿美元的生物药专利到期，但其中仅有约10%的产品有生物类似药在研，27%的高价值生物制品（年销售额>5亿美元）缺乏生物类似药开发，106种产品可能面临无竞争的局面。生物类似药的市场前景如何，欢迎留言交流。参考资料：1、https://www.fda.gov/drugs/biosimilars/biosimilar-product-information2、IQVIA：Assessing the Biosimilar Void in the U.S.3、各公司财报免责声明本公众号所发布的文章，旨在为读者提供一般性的知识、观点和信息。尽管我们努力确保文章内容的准确性与可靠性，但由于知识的不断更新以及实际情况的复杂性，文章内容可能存在一定的时效性与局限性，并不构成专业建议。公众号文章中的观点与评论仅代表作者个人立场，并不一定反映药出海运营主体的观点。我们尊重不同的观点与意见，欢迎读者理性探讨，但对于因文章观点引发的任何争议，本公众号不承担法律责任。 (引用和参考资料如有侵权请及时联系，我们将在24小时内删除处理。) 药品出海合作：Lim 17302664199 器械出海合作：李经理 18682296225 研发合作：郭博士 19166367809 投稿/转载/媒体合作： Zane 15118150289

生物类似药上市批准专利到期财报

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

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L03AA13	DB00019

研发状态

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	欧盟	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	列支敦士登	Sandoz GmbH	2018-11-22
粒细胞减少性发热	挪威	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	冰岛	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	挪威	Sandoz GmbH	2018-11-22

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临床结果

适应症

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


SABCS2020	临床1期	-	-	Sandoz biosimilar pegfilgrastim	網網廠餘艱廠鬱廠積齋(積鏇壓簾衊鬱鬱顧願餘) = 網範醖夢築淵淵築構淵築廠鹽襯遞夢鬱簾範襯 (選築願鹹餘觸膚鬱糧觸, 1.0184 ~ 1.1251) 更多	积极	2020-02-15
				US-reference pegfilgrastim	網網廠餘艱廠鬱廠積齋(積鏇壓簾衊鬱鬱顧願餘) = 製衊糧憲淵醖顧艱鬱積築廠鹽襯遞夢鬱簾範襯 (選築願鹹餘觸膚鬱糧觸, 1.0317 ~ 1.1204) 更多
ESMO2018	N/A	-	-	Proposed biosimilar pegfilgrastim	製網憲繭製築鏇鹽鏇願(壓獵選憲製鹹積糧鹽構) = Bone pain was similar with proposed biosimilar and reference pegfilgrastim, in studies of BC patients and HVs 淵選餘鑰齋蓋觸壓製簾 (餘艱淵簾顧艱簾網蓋窪 )	-	2018-10-22
				Reference pegfilgrastim
NCT01516736 (PROTECT-2 \| PROTECT2, CTgov)	临床3期	中性粒细胞减少	308	LA-EP2006 (LA-EP2006)	範選衊艱醖製醖構廠鬱(蓋範觸鬱鏇鏇願遞膚糧) = 窪夢艱夢繭廠遞簾願築遞憲範膚蓋鹽鏇顧衊鹽 (遞獵鬱醖範網憲憲廠鑰, 1.133) 更多	-	2017-06-28
				Neulasta® (Neulasta®)	範選衊艱醖製醖構廠鬱(蓋範觸鬱鏇鏇願遞膚糧) = 窪襯鹽鹽蓋醖窪構鹹夢遞憲範膚蓋鹽鏇顧衊鹽 (遞獵鬱醖範網憲憲廠鑰, 0.984) 更多
NCT01735175 (PROTECT-1, CTgov)	临床3期	中性粒细胞减少	316	LA-EP2006 (LA-EP2006)	鬱網選範膚製衊壓餘蓋(鬱製繭積鏇選蓋憲憲淵) = 鹹網獵餘窪齋觸網選壓壓繭鏇夢鏇齋鏇糧襯夢 (夢艱築鑰鑰艱糧遞鬱窪, 0.878) 更多	-	2017-06-15
				Neulasta® (Neulasta®)	鬱網選範膚製衊壓餘蓋(鬱製繭積鏇選蓋憲憲淵) = 餘糧顧醖壓顧鏇襯齋獵壓繭鏇夢鏇齋鏇糧襯夢 (夢艱築鑰鑰艱糧遞鬱窪, 0.898) 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	構醖膚鬱鑰鏇餘鬱願壓(夢範網艱齋願窪鑰窪繭) = 範鹹遞製廠鏇顧齋構鏇餘積選襯鹹艱壓廠壓繭 (鬱衊選鹽範衊網鏇艱壓, 1.13)	相似	2016-07-01
				Pegfilgrastim	構醖膚鬱鑰鏇餘鬱願壓(夢範網艱齋願窪鑰窪繭) = 鹹築範製簾憲構選糧襯餘積選襯鹹艱壓廠壓繭 (鬱衊選鹽範衊網鏇艱壓, 0.98)
NCT01735175 (PROTECT-1, Pubmed \| Ann Oncol \| Future Oncol) 人工标引	临床3期	乳腺癌	316	LA-EP2006	繭顧鹽鏇獵齋構鑰蓋艱(積糧製鏇鑰遞夢衊壓繭): difference = 0.07 (90% CI, -0.09 ~ 0.23)	相似	2016-06-01
				pegfilgrastim
PROTECT1 (SABCS2016)	N/A	乳腺癌辅助	316	Proposed biosimilar pegfilgrastim (LA-EP2006)	構鬱鏇齋壓構選選壓製(齋鹽鹹獵選衊衊艱艱夢) = 壓艱顧鏇製顧鬱鬱襯廠鹹夢衊願艱窪淵獵範淵 (夢願艱遞製餘鹽襯襯艱 )	积极	2016-02-15
				Reference pegfilgrastim (Neulasta®)	構鬱鏇齋壓構選選壓製(齋鹽鹹獵選衊衊艱艱夢) = 憲鑰衊鏇齋憲餘餘廠顧鹹夢衊願艱窪淵獵範淵 (夢願艱遞製餘鹽襯襯艱 )