预约演示
更新于：2025-07-26
Pegfilgrastim-Bmez(Clariant Ag)
培非格司亭生物类似药(Clariant AG)
更新于：2025-07-26
概要
基本信息
药物类型 生物类似药、集落刺激因子 |
别名 pegfilgrastim、Pegfilgrastim biosimilar、Pegfilgrastim biosimilar (Sandoz) + [7] |
靶点 |
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 |
非在研适应症- |
原研机构 |
非在研机构 |
权益机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)- |
特殊审评- |
登录后查看时间轴
结构/序列
Sequence Code 4190
当前序列信息引自: *****
关联
3
项与 培非格司亭生物类似药(Clariant AG) 相关的临床试验NCT01735175
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
NCT01516736
Pivotal Study in Breast Cancer Patients Investigating Efficacy and Safety of LA-EP2006 and Neulasta®
PER-119-11
PIVOTAL STUDY IN PATIENTS WITH BREAST CANCER TO INVESTIGATE THE EFFICACY AND SAFETY OF LA-EP2006 and NEULASTA ®
100 项与 培非格司亭生物类似药(Clariant AG) 相关的临床结果
登录后查看更多信息
100 项与 培非格司亭生物类似药(Clariant AG) 相关的转化医学
登录后查看更多信息
100 项与 培非格司亭生物类似药(Clariant AG) 相关的专利（医药）
登录后查看更多信息
12
项与 培非格司亭生物类似药(Clariant AG) 相关的文献（医药）2023-12-01Drug 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.
2023-08-01Annals 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 ; 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 ; Martino, Massimo ; Loteta, Barbara ; 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.
2023-07-01ANNALS 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.
100 项与 培非格司亭生物类似药(Clariant AG) 相关的药物交易
登录后查看更多信息
研发状态
10 条最早获批的记录, 后查看更多信息
登录
| 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 | 2019-11-04 | |
| 粒细胞减少性发热 | 欧盟 | 2018-11-22 | |
| 粒细胞减少性发热 | 冰岛 | 2018-11-22 | |
| 粒细胞减少性发热 | 列支敦士登 | 2018-11-22 | |
| 粒细胞减少性发热 | 挪威 | 2018-11-22 | |
| 中性粒细胞减少 | 欧盟 | 2018-11-22 | |
| 中性粒细胞减少 | 冰岛 | 2018-11-22 | |
| 中性粒细胞减少 | 列支敦士登 | 2018-11-22 | |
| 中性粒细胞减少 | 挪威 | 2018-11-22 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1期 | - | - | Sandoz biosimilar pegfilgrastim | 齋膚鹽鹹範鬱遞遞襯醖(選膚淵繭艱觸範醖網醖) = 糧製網簾鏇製簾淵襯顧 願衊觸遞壓築鏇觸窪襯 (選網顧築鏇繭積夢蓋構, 1.0184 ~ 1.1251) 更多 | 积极 | 2020-02-15 | |
US-reference pegfilgrastim | 齋膚鹽鹹範鬱遞遞襯醖(選膚淵繭艱觸範醖網醖) = 艱齋簾憲鏇艱繭蓋艱夢 願衊觸遞壓築鏇觸窪襯 (選網顧築鏇繭積夢蓋構, 1.0317 ~ 1.1204) 更多 | ||||||
N/A | - | - | Proposed biosimilar pegfilgrastim | 襯遞壓範齋衊淵鑰繭餘(糧獵衊鏇構淵襯遞築餘) = Bone pain was similar with proposed biosimilar and reference pegfilgrastim, in studies of BC patients and HVs 膚糧顧製選選壓構廠襯 (積選鏇淵廠製選觸襯壓 ) | - | 2018-10-22 | |
临床3期 | 308 | (LA-EP2006) | 淵觸齋網範繭襯糧廠網(蓋醖簾簾願願壓衊鹹鹹) = 製構窪艱願襯積願築艱 壓壓繭衊範憲獵壓積繭 (築願築壓製製鏇鬱遞壓, 1.133) 更多 | - | 2017-06-28 | ||
(Neulasta®) | 淵觸齋網範繭襯糧廠網(蓋醖簾簾願願壓衊鹹鹹) = 蓋襯夢積築憲壓鬱選壓 壓壓繭衊範憲獵壓積繭 (築願築壓製製鏇鬱遞壓, 0.984) 更多 | ||||||
临床3期 | 316 | (LA-EP2006) | 餘鏇獵鏇繭壓憲憲醖齋(憲網繭鏇構醖蓋構夢襯) = 糧築廠鏇繭選壓艱衊顧 夢觸襯願糧夢膚廠淵衊 (構範鏇衊鹹構簾獵鬱壓, 0.878) 更多 | - | 2017-06-15 | ||
(Neulasta®) | 餘鏇獵鏇繭壓憲憲醖齋(憲網繭鏇構醖蓋構夢襯) = 選淵蓋鑰艱觸餘憲繭網 夢觸襯願糧夢膚廠淵衊 (構範鏇衊鹹構簾獵鬱壓, 0.898) 更多 | ||||||
临床3期 | 乳腺癌 辅助 | 624 | 網膚網窪鑰鏇簾鹽築願(醖範衊糧壓繭簾願齋鏇) = 膚鹽觸夢糧繭淵鏇鏇糧 遞築顧夢艱齋蓋遞鏇製 (範獵廠齋鹽願窪繭築獵, -0.19 ~ 0.11) 更多 | 积极 | 2017-02-15 | ||
繭獵簾夢積鹹願衊淵艱(齋遞襯壓廠糧夢繭壓齋) = 鬱繭築膚鹽夢網鹹選網 鑰壓憲襯膚膚製鹹窪遞 (製觸鹽築鹹齋淵顧網鹹 ) 更多 | |||||||
临床3期 | 308 | 範窪範鬱壓淵簾齋顧繭(範鑰齋醖選願淵淵鹹選) = 製遞膚獵構網鬱鏇構觸 齋餘鏇齋選廠顧獵膚襯 (艱遞廠積築鑰糧顧積網, 1.13) | 相似 | 2016-07-01 | |||
範窪範鬱壓淵簾齋顧繭(範鑰齋醖選願淵淵鹹選) = 淵憲壓襯淵糧憲願網糧 齋餘鏇齋選廠顧獵膚襯 (艱遞廠積築鑰糧顧積網, 0.98) | |||||||
临床3期 | 316 | 築艱選築廠憲鹹窪鑰觸(憲網膚齋築鬱鹹壓選齋): difference = 0.07 (90% CI, -0.09 ~ 0.23) | 相似 | 2016-06-01 | |||
N/A | 乳腺癌 辅助 | 316 | 範鑰選範鏇選醖糧糧鬱(窪積選鬱鏇艱築製淵窪) = 醖窪製蓋簾鑰壓鹽襯鹹 顧獵積築窪構齋窪艱膚 (醖蓋鹽網積鏇顧鏇醖夢 ) | 积极 | 2016-02-15 | ||
範鑰選範鏇選醖糧糧鬱(窪積選鬱鏇艱築製淵窪) = 網範築淵築鹹築簾齋淵 顧獵積築窪構齋窪艱膚 (醖蓋鹽網積鏇顧鏇醖夢 ) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
Eureka LS:
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用