培非格司亭生物类似药（Biocon）(Pegfilgrastim-Jmdb) - 药物靶点：CSF-3R_在研适应症：中性粒细胞减少，粒细胞减少性发热，化疗引起的发热性中性粒细胞减少症_专利_临床

概要

基本信息

药物类型

生物类似药、集落刺激因子

别名

Fulphila、PEG G CSF、pegfilgrastim

+ [3]

靶点

CSF-3R

作用方式

激动剂

作用机制

CSF-3R激动剂(巨噬细胞集落刺激因子3受体激动剂)

治疗领域

血液及淋巴系统疾病

在研适应症

中性粒细胞减少粒细胞减少性发热化疗引起的发热性中性粒细胞减少症

非在研适应症

乳腺癌

原研机构

Biocon Ltd.

在研机构

BGP Pharma ULCBiocon Biologics Ireland Ltd.Mylan Pharmaceuticals, Inc.

+ [2]

非在研机构

Mylan NV

权益机构

Biocon Ltd.

Mylan NV

最高研发阶段批准上市

首次获批日期

美国 (2018-06-04),

化疗引起的发热性中性粒细胞减少症

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 4190

当前序列信息引自: *****

关联

22

项与培非格司亭生物类似药（Biocon）相关的临床试验

JPRN-jRCT2071210138

/ Completed临床1期IIT

To compare the Pharmacokinetics (PK) / Pharmacodynamics(PD)of a single subcutaneous (sc) injection (3.6 mg) of MYL-1401H and G-Lasta in Japanese healthy adult volunteers

开始日期2022-03-17

申办/合作机构-

NCT05573386

/ Unknown statusN/AIIT

A Single Center, Prospective Study to Compare the Quality and Quantity of the Cellular Content of M-PRP Harvested After Peripheral Mobilization of Progenitor Cells Using Filgrastim Versus Pegfilgrastim

The goal of this prospective, observational study is to compare the quality and quantity of the cellular content of platelet-rich plasma harvested after administering one of two cell-stimulating proteins, filgrastim and pegfilgrastim. The main question it aims to answer is:
• Will participants have a similar cellular content when comparing a 4-day filgrastim treatment to a one-day pegfilgrastim treatment?
Participants will have the following intervention administered:
* 130mL of blood will be drawn on the first visit after consent and in followup visits after administering treatment (4 days for filgrastim, 7 days for pegfilgrastim)
* Half of all participants will receive filgrastim first, followed by pegfilgrastim 8 weeks after filgrastim treatment concludes. The other half will receive the treatments in reverse order
Researchers will compare the quality and quantity of cell content after each treatment administration as well as comparing differences in data dependent on which order treatment was given.

开始日期2021-08-09

申办/合作机构

Andrews Research & Education Foundation, Inc.

IRCT20180119038433N3

/ Suspended临床3期IIT

Comparison of the effect of pegfilgrastim with filgrastim on the neutrophil count of cancer patients under chemotherapy, a randomization clinical trial.

开始日期2020-10-22

申办/合作机构

Semnan University

100 项与培非格司亭生物类似药（Biocon）相关的临床结果

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100 项与培非格司亭生物类似药（Biocon）相关的转化医学

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100 项与培非格司亭生物类似药（Biocon）相关的专利（医药）

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13

项与培非格司亭生物类似药（Biocon）相关的文献（医药）

2023-08-01·Clinical pharmacology in drug development

Clinical Impact of Antipolyethylene Glycol (PEG) Antibody in Hematological Patients Administered PEGylated‐Granulocyte Colony‐Stimulating Factor

Article

作者: Ishizawa, Keisuke ; Ishida, Tatsuhiro ; Taro, Shimizu ; Nakamura, Shingen ; Okada, Naoto ; Ando, Hidenori ; Goda, Mitsuhiro ; Kitahara, Takashi ; Abe, Masahiro

Abstract:

Polyethylene glycol (PEG) is a polymer covalently attached to proteins to improve their half‐life and efficacy. We previously reported that the PEGylated granulocyte colony‐stimulating factor (PEG‐G‐CSF) is immunogenic, which could adversely impact drug efficacy and safety in animal models. Here, we analyzed the relationship between anti‐PEG antibody titers and the clinical impact of PEG‐G‐CSF in 19 hematological patients. A gradual decrease of anti‐PEG antibody titers from baseline was observed after PEG‐G‐CSF administration. Of the 19 participants, 10 were assessed for noninfectious fever after the first administration of PEG‐G‐CSF and three experienced this reaction. The receiver operating characteristic curve revealed that the cut‐off values of pretreated anti‐PEG IgM and IgG titers for noninfectious fever were set at 5.0 and 96.6 U/mL, respectively. All patients who experienced noninfectious fever had anti‐PEG antibody titers above this cut‐off value (P = .033). An enzyme‐linked immunosorbent assay revealed that some anti‐PEG antibodies in patients with anti‐PEG antibody titers above the cut‐off value reacted with the PEGylated liposome. These results indicate the reactivity of the anti‐PEG antibodies to PEGylated therapeutics observed in hematologic patients and the possibility of the relationship between high titers of anti‐PEG antibodies and the development of adverse events after PEG‐G‐CSF administration.

2023-02-01·Journal of managed care & specialty pharmacy

Comparative effectiveness of pegfilgrastim biosimilars vs originator for prevention of febrile neutropenia: A retrospective cohort study

Article

作者: Brown, Joshua D ; Heldermon, Coy D ; Park, Haesuk ; Vouri, Scott M ; Wang, Ching-Yu

BACKGROUND: Real-world evidence on the comparative effectiveness of pegfilgrastim biosimilars compared with the originator product is limited. OBJECTIVE: To compare the risk of febrile neutropenia (FN) among users of pegfilgrastim biosimilars (pegfilgrastim-jmdb and pegfilgrastim-cbqv) and the originator product. METHODS: A retrospective cohort study was conducted using 2019 IBM MarketScan databases to assess comparative effectiveness of pegfilgrastim originator and biosimilars for prevention of FN among patients receiving myelosuppressive chemotherapy. Patients with cancer, including breast, lung, colorectal, esophageal and gastric, pancreatic, prostate, ovarian, and non-Hodgkin lymphomas, initiating myelosuppressive chemotherapy courses were selected. We further selected patients who used pegfilgrastim originator and biosimilars within 3 days of chemotherapy completion. FN-associated hospitalizations were measured by International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis codes. After 1:1 propensity score matching, we used equivalence (with a margin of 6%) hypothesis tests to compare FN-related hospitalization risk in the first cycle and across all cycles between biosimilars and originator users. RESULTS: A total of 2,045 patients were included, of which 445 (21.8%) used pegfilgrastim-jmdb, 636 (31.1%) used pegfilgrastim-cbqv, and 964 (47.1%) used pegfilgrastim originator. After matching, 13 out of 445 originator users and 17 out of 445 pegfilgrastim-jmdb users developed FN after the first chemotherapy cycle (risk difference was 0.9%; P < 0.001 for equivalence test indicating statistical equivalence). After matching, 14 out of 633 originator users and 16 out of 633 pegfilgrastim-cbqv users developed FN (risk difference was 0.32%; P < 0.001 for equivalence test indicating statistical equivalence). Results across all cycles (including the first cycle) were consistent with that in the first cycle. CONCLUSIONS: In this real-world study of patients with cancer receiving myelosuppressive chemotherapy, there was no difference in FN risk between patients receiving pegfilgrastim originator and biosimilars in the first cycle and across all cycles. These results add further to the current evidence on pegfilgrastim biosimilars and support wider adoption of pegfilgrastim biosimilars among payers, providers, and patients. Future studies assessing the tolerability, side effects, and other safety issues of pegfilgrastim biosimilars are needed.

2022-07-01·Journal of managed care & specialty pharmacy

Patient out-of-pocket and payer costs for pegfilgrastim originator vs biosimilars as primary prophylaxis of febrile neutropenia in the first cycle among a commercially insured population

Article

作者: Brown, Joshua D ; Heldermon, Coy D ; Park, Haesuk ; Wang, Ching-Yu ; Vouri, Scott M

BACKGROUND: It is unknown whether using pegfilgrastim biosimilars is cost saving in a real-world setting. OBJECTIVE: To compare medical costs including pegfilgrastim drug costs and febrile neutropenia (FN) treatment and management costs between pegfilgrastim biosimilars (pegfilgrastim-jmdb, pegfilgrastim-cbqv) and originator users for primary prophylaxis of febrile neutropenia. METHODS: A retrospective cohort study using 2019 IBM MarketScan Commercial and Medicare Supplemental databases was conducted in adult patients with cancer initiating myelosuppressive chemotherapy courses. At least 2 diagnoses of the same cancer (at least 7 days apart) were required within 30 days of the chemotherapy initiation date. Pegfilgrastim (excluding on-body injector) costs included drug costs only (excluding administration fees). FN-related costs included all FN-related health care utilizations that were defined as having neutropenia, fever, or infection diagnosis. Per-patient per-cycle (PPPC) out-of-pocket (OOP) costs, health plan costs, and total costs were compared between originator (excluding on-body injector) and biosimilars users in the first cycle. A generalized linear model and a 2-part model were used. RESULTS: A total of 1,930 patients were included, of whom 884 (45.8%) used pegfilgrastim originator, 427 (22.1%) used pegfilgrastim-jmdb, and 619 (32.1%) used pegfilgrastim-cbqv. Adjusted PPPC OOP pegfilgrastim costs in the first cycle were significantly lower for the biosimilars vs the originator ($182 for pegfilgrastim-jmdb and $159 for pegfilgrastim-cbqv vs $299 for originator, P < 0.0001 for both comparisons). However, there was no difference in health plan costs ($5,783 for pegfilgrastim-jmdb and $5,845 for pegfilgrastim-cbqv vs $5,618 for originator) and total costs. In addition, no difference was observed for adjusted PPPC FN treatment and management OOP costs, health plan costs, and total costs in the first cycle. FN treatment OOP costs were $192 for originator, $197 for pegfilgrastim-jmdb (P = 0.958), and $240 for pegfilgrastim-cbqv (P = 0.680). FN treatment health plan costs were $2,804 for originator, $2,970 for pegfilgrastim-jmdb (P = 0.692), and $2,745 for pegfilgrastim-cbqv (P = 0.879). CONCLUSIONS: In a commercially insured population, using pegfilgrastim biosimilars in the first cycle for primary prophylaxis of FN led to cost savings for patients but not payers. No difference in FN-related costs was observed.

29

项与培非格司亭生物类似药（Biocon）相关的新闻（医药）

2025-04-11

·Pharmaceutical Technology

FDA approves Biocon Biologics’ bevacizumab biosimilar for cancer

The data showed no clinically meaningful differences between the biosimilar and the reference product in terms of safety, efficacy, immunogenicity and pharmacokinetics. Credit: Gorodenkoff/Shutterstock. Biocon Biologics has gained approval from the US Food and Drug Administration (FDA) for the intravenous use of Jobevne (bevacizumab-nwgd), a biosimilar to the reference Avastin (bevacizumab). Jobevne is a recombinant humanised monoclonal antibody which functions as a vascular endothelial growth factor inhibitor, targeting the cancer and restricting the supply of blood to tumours. The approval bolsters the company’s biosimilar oncology portfolio in the US, which includes Fulphila (Pegfilgrastim-jmdb) and Ogivri (Trastuzumab-dkst). The company has been marketing bevacizumab under the name Abevmy in Europe, where it was approved in February 2021. It also gained approval in November of the same year in Canada. The FDA approval was supported by a comprehensive package comprising comparative pharmacokinetic, efficacy, nonclinical, functional, safety, analytical and structural data that demonstrated Jobevne’s high similarity to the reference product. In safety, efficacy, immunogenicity and pharmacokinetics, the data showed no clinically meaningful differences between Jobevne and Avastin. Biocon Biologics CEO and managing director Shreehas Tambe stated: “The US FDA approval of Jobevne (bevacizumab-nwgd) is a significant milestone — our seventh biosimilar approved in the US and a strong addition to our robust oncology portfolio. “It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients.” Biocon Biologics has commercialised nine biosimilars from a pipeline of 20 products in the US, Australia, Canada, Japan and Europe. Its development pipeline of biosimilar assets spans oncology, ophthalmology, immunology, diabetology and other non-communicable conditions. In August 2024, the company reached a settlement and licence agreement with Janssen Biotech, Janssen Sciences Ireland and Johnson & Johnson (together called Janssen) for the commercialisation of Bmab 1200 (bUstekinumab), a proposed biosimilar to Stelara.

上市批准引进/卖出免疫疗法

2025-04-10

·PipelineReview

Biocon Biologics Announces U.S. FDA Approval for Jobevne™, Biosimilar Bevacizumab, Expanding Its Oncology Portfolio

BRIDGEWATER, NJ, USA and BENGALURU, Karnataka, India I April 10, 2025 I Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (U.S. FDA) has approved Jobevne™ (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. JOBEVNE, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin® (bevacizumab). JOBEVNE is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis – combating cancer by restricting blood supply to the tumor. The approval of JOBEVNE expands Biocon Biologics’ biosimilar oncology portfolio in the United States, which also includes OGIVRI (Trastuzumab-dkst) and FULPHILA (Pegfilgrastim-jmdb). The Company also markets Bevacizumab in Europe (approved February 2021) and Canada (approved November 2021) under the name ABEVMY. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd. , said: “The U.S. FDA approval of JOBEVNE™ (bevacizumab-nwgd) is a significant milestone—our seventh biosimilar approved in the U.S. and a strong addition to our robust oncology portfolio. It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients.” In the U.S., sales of bevacizumab were approximately $2.0 billion in 2023.** Biocon Biologics is a leading global player in biosimilars and insulin production and has achieved many “firsts” in the industry including the first to receive approval of a trastuzumab in the United States, OGIVRI (Trastuzumab-dkst), as well as FULPHILA (Pegfilgrastim-jmdb) and the first U.S. approval of an interchangeable biosimilar for SEMGLEE (insulin glargine). Serving over 5 million patients annually, Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including seven approved biosimilars in the United States and six in Canada, with a robust development pipeline of 20 biosimilar assets, including insulins and monoclonal antibodies spanning multiple therapy areas. About JOBEVNE: The approval for JOBEVNE (bevacizumab-nwgd) was based on a comprehensive package of comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical and functional data, which confirmed that JOBEVNE is highly similar to Avastin® (bevacizumab). The data demonstrated that there were no clinically meaningful differences between JOBEVNE and Avastin® in terms of pharmacokinetics, safety, efficacy, and immunogenicity. INDICATIONS AND USAGE: JOBEVNE is a vascular endothelial growth factor inhibitor indicated for the treatment of: * Limitations of Use: JOBEVNE is not indicated for adjuvant treatment of colon cancer. JOBEVNE is a trademark of Biosimilars Newco Limited, a Biocon Biologics Company. OGIVRI, FULPHILA, SEMGLEE and ABEVMY are registered trademarks of Biosimilars Newco Limited, a Biocon Biologics Company. BIOCON BIOLOGICS and the Biocon Biologics Logo are registered trademarks of Biocon Biologics Limited. All other trademarks are the property of their respective owners. **Sales projections are based on Biocon Biologics’ analysis of IQVIA 2023 data. About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL) , a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its ‘lab to market’ capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. Biocon Biologics has commercialized nine biosimilars from its pipeline of 20 products in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It’s pipeline has several biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. The Company has many ‘firsts’ to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website www.bioconbiologics.com ; Follow us on X (formerly Twitter ): @BioconBiologics and LinkedIn : Biocon Biologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: www.biocon.com ; Follow-us on X (formerly Twitter ) @bioconlimited and LinkedIn : Biocon for company updates. SOURCE: Biocon Biologics

上市批准免疫疗法

2025-04-09

·Pharmaindustrial

Biocon Biologics Announces USFDA Approval of JOBEVNE Biosimilar for Cancer Treatment

Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd announced that the US Food and Drug Administration (US FDA) has approved Jobevne™ (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. JOBEVNE, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin® (bevacizumab). JOBEVNE is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis – combating cancer by restricting blood supply to the tumor. The approval of JOBEVNE expands Biocon Biologics' biosimilar oncology portfolio in the United States, which also includes OGIVRI (Trastuzumab-dkst) and FULPHILA (Pegfilgrastim-jmdb). The Company also markets Bevacizumab in Europe (approved February 2021) and Canada (approved November 2021) under the name ABEVMY. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., said: "The U.S. FDA approval of JOBEVNE™ (bevacizumab-nwgd) is a significant milestone—our seventh biosimilar approved in the U.S. and a strong addition to our robust oncology portfolio. It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients." In the U.S., sales of bevacizumab were approximately USD 2.0 billion in 2023.

上市批准免疫疗法生物类似药

100 项与培非格司亭生物类似药（Biocon）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
中性粒细胞减少	欧盟	Biocon Biologics Ireland Ltd.	2018-11-20
中性粒细胞减少	冰岛	Biocon Biologics Ireland Ltd.	2018-11-20
中性粒细胞减少	列支敦士登	Biocon Biologics Ireland Ltd.	2018-11-20
中性粒细胞减少	挪威	Biocon Biologics Ireland Ltd.	2018-11-20
粒细胞减少性发热	澳大利亚	Alphapharm Pty Ltd.	2018-08-17
化疗引起的发热性中性粒细胞减少症	美国	Mylan Pharmaceuticals, Inc.	2018-06-04

未上市

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适应症	最高研发状态	国家/地区	公司	日期
乳腺癌	临床3期	保加利亚	Mylan NV	2015-03-01
乳腺癌	临床3期	格鲁吉亚	Mylan NV	2015-03-01
乳腺癌	临床3期	德国	Mylan NV	2015-03-01
乳腺癌	临床3期	匈牙利	Mylan NV	2015-03-01
乳腺癌	临床3期	波兰	Mylan NV	2015-03-01
乳腺癌	临床3期	乌克兰	Mylan NV	2015-03-01

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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


ASCO_GI2023	临床2期	食管癌新辅助	67	Day 3 PG-containing DCF	鬱遞齋憲遞餘蓋顧衊遞(窪範憲糧鹽膚鏇壓齋襯) = 齋積醖遞鑰築糧淵襯醖淵獵憲鬱觸鏇選艱壓憲 (糧壓簾築衊鬱膚簾鹽夢 ) 更多	-	2023-01-24
				No PG DCF	鬱遞齋憲遞餘蓋顧衊遞(窪範憲糧鹽膚鏇壓齋襯) = 積醖獵構鏇鹹繭網構糧淵獵憲鬱觸鏇選艱壓憲 (糧壓簾築衊鬱膚簾鹽夢 ) 更多
ESMO_ASIA2022	N/A	侵袭性非霍奇金淋巴瘤	263	PEG G-CSF	鹽憲製積鹹夢齋鏇齋選(築齋築選構蓋膚顧願淵) = 餘遞鏇襯顧鑰蓋積齋遞製窪餘簾製夢餘簾繭窪 (選鏇範鏇膚醖膚齋簾糧 ) 更多	-	2022-12-03
				Non-PEG G-CSF	鹽憲製積鹹夢齋鏇齋選(築齋築選構蓋膚顧願淵) = 築餘糧齋衊積鑰製鹹顧製窪餘簾製夢餘簾繭窪 (選鏇範鏇膚醖膚齋簾糧 ) 更多
ASCO_GI2022	N/A	食管癌新辅助	52	DCF with prophylactic pegfilgrastim (D3PG)	繭顧淵鬱廠餘繭淵醖鹹(糧膚艱願齋積廠餘繭窪) = 憲築鏇構獵範製襯齋鏇餘顧願積鏇衊觸製製膚 (艱壓構廠獵築憲鏇窪襯 ) 更多	积极	2022-01-19
				Standard DCF (NPG)	繭顧淵鬱廠餘繭淵醖鹹(糧膚艱願齋積廠餘繭窪) = 糧衊鑰鏇範鏇蓋襯衊淵餘顧願積鏇衊觸製製膚 (艱壓構廠獵築憲鏇窪襯 ) 更多
ASCO2021	N/A	慢性淋巴细胞白血病 \| 淋巴瘤	116	Pegfilgrastim (PFG)	憲蓋網壓醖壓製選艱鹽(選積膚窪廠積觸製夢簾) = 簾膚繭醖糧簾願醖鑰鹹鏇衊壓廠網觸鹹構艱鹹 (夢衊蓋鏇齋糧餘壓鹽範 ) 更多	-	2021-05-28
				PFG-cbqv	憲蓋網壓醖壓製選艱鹽(選積膚窪廠積觸製夢簾) = 膚醖鏇簾願繭選選夢夢鏇衊壓廠網觸鹹構艱鹹 (夢衊蓋鏇齋糧餘壓鹽範 ) 更多
ASCO2021	N/A	非霍奇金淋巴瘤	100	Pegfilgrastim	醖衊構廠範鬱壓簾顧憲(廠淵顧範鏇糧夢壓製製) = 鑰構廠築遞憲鹽鹽衊艱願鑰構獵淵齋齋夢廠糧 (遞壓範鏇簾願衊願廠壓 ) 更多	积极	2021-05-28
				Pegfilgrastim-cbqv	積廠鏇簾築積夢繭鏇夢(製積鬱網艱鑰窪範艱窪) = 選醖窪醖壓鑰鹽構蓋遞積襯艱製顧夢憲繭淵範 (膚蓋簾鑰遞遞衊襯憲選 ) 更多
ASCO2020	N/A	-	-	Pegfilgrastim	窪鑰顧簾憲製糧膚積齋(鹽廠觸艱鑰獵糧構艱顧) = 繭淵窪餘襯壓製顧憲築遞範壓憲鏇願夢憲觸構 (製憲衊選構鬱衊鑰鏇襯 )	积极	2020-05-25
				Biosimilar Pegfilgrastim	蓋蓋築繭獵遞顧鹽艱鹽(膚網夢獵鏇夢衊構憲積) = 衊壓簾窪艱廠獵鹽窪淵鏇膚選簾窪顧襯糧鹽膚 (鏇鏇窪衊獵獵積鬱廠築 )
ASCO_GI2020	N/A	胃肠道肿瘤	157	Same-day pegfilgrastim	築鑰艱獵鏇鑰築構簾鑰(夢壓壓獵鹹齋鑰獵鏇鏇) = 鏇構顧艱顧夢選繭壓觸範淵蓋廠選範積構廠餘 (膚繭觸憲觸遞襯壓觸醖, 450 ~ 23800)	积极	2020-02-04
ASCO2019	N/A	前列腺癌	65	As-needed filgrastim (ANF)	衊顧鑰淵壓遞餘壓齋鏇(鏇鏇鹹遞觸築顧襯壓鹽) = 簾醖衊衊鹽艱糧築鬱顧襯繭簾醖構選糧蓋積鏇 (餘繭衊築鏇繭簾獵鹽觸 ) 更多	积极	2019-05-26
				Prophylactic pegfilgrastim (PPF)	衊顧鑰淵壓遞餘壓齋鏇(鏇鏇鹹遞觸築顧襯壓鹽) = 觸醖繭夢蓋製積繭簾構襯繭簾醖構選糧蓋積鏇 (餘繭衊築鏇繭簾獵鹽觸 ) 更多
ASCO2019	N/A	转移性结直肠癌	-	Pegfilgrastim-treated	繭廠繭簾獵願遞衊範夢(齋範衊範網淵鹹淵蓋憲) = 蓋鹹衊築簾廠蓋鏇衊艱淵選齋願鹹襯憲鹹積艱 (膚願衊淵遞廠簾獵衊鬱 ) 更多	不佳	2019-05-26
				pegfilgrastim (Peg-untreated)	繭廠繭簾獵願遞衊範夢(齋範衊範網淵鹹淵蓋憲) = 觸壓觸範齋顧憲齋蓋繭淵選齋願鹹襯憲鹹積艱 (膚願衊淵遞廠簾獵衊鬱 ) 更多
NCT02467868 (Pubmed) 人工标引	临床3期	中性粒细胞减少	135	MYL-1401H	夢壓衊遞鏇鹽憲膚膚鹹(網蓋鹹願鹹顧簾鏇網鬱) = 願壓製遞淵選鹽糧壓積醖餘窪簾齋鏇襯襯醖廠 (繭鑰壓壓衊獵願鬱積鹹, 0.93) 更多	相似	2019-05-01
				pegfilgrastim	夢壓衊遞鏇鹽憲膚膚鹹(網蓋鹹願鹹顧簾鏇網鬱) = 窪餘淵觸遞鹽憲蓋糧夢醖餘窪簾齋鏇襯襯醖廠 (繭鑰壓壓衊獵願鬱積鹹, 1.10) 更多