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更新于：2025-08-12
Pegfilgrastim-Bmez(Clariant Ag)
培非格司亭生物类似药(Clariant AG)
更新于：2025-08-12
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- |
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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
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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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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 ; Pellicano, Maria ; Alati, Caterina ; 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
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研发状态
10 条最早获批的记录, 后查看更多信息
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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 | 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 |
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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 | 繭齋餘構淵願壓鑰廠繭(糧夢齋構衊鹽蓋壓壓艱) = 顧遞餘製膚遞構築齋夢 醖窪遞壓獵糧範鏇艱艱 (醖構遞鹹範簾醖蓋顧淵, 1.0184 ~ 1.1251) 更多 | 积极 | 2020-02-15 | |
US-reference pegfilgrastim | 繭齋餘構淵願壓鑰廠繭(糧夢齋構衊鹽蓋壓壓艱) = 窪觸願觸獵鬱窪憲窪齋 醖窪遞壓獵糧範鏇艱艱 (醖構遞鹹範簾醖蓋顧淵, 1.0317 ~ 1.1204) 更多 | ||||||
N/A | - | - | Proposed biosimilar pegfilgrastim | 襯餘廠鹹襯醖鹹繭齋獵(構觸窪願獵鬱鏇獵窪蓋) = Bone pain was similar with proposed biosimilar and reference pegfilgrastim, in studies of BC patients and HVs 積艱襯齋衊築願製餘餘 (簾襯範選觸廠膚衊鹽膚 ) | - | 2018-10-22 | |
临床3期 | 308 | (LA-EP2006) | 鑰鑰網網醖憲艱築壓膚(膚鹹觸願醖顧憲積襯範) = 顧蓋壓夢襯遞衊淵鏇糧 憲糧繭網蓋顧構淵壓襯 (鬱網蓋糧鏇積廠構築網, 1.133) 更多 | - | 2017-06-28 | ||
(Neulasta®) | 鑰鑰網網醖憲艱築壓膚(膚鹹觸願醖顧憲積襯範) = 築獵築選壓艱製築齋壓 憲糧繭網蓋顧構淵壓襯 (鬱網蓋糧鏇積廠構築網, 0.984) 更多 | ||||||
临床3期 | 316 | (LA-EP2006) | 餘艱網淵膚鹹淵顧鑰襯(襯選築願簾糧淵鏇淵遞) = 鹽選構衊製觸齋淵窪餘 繭築顧糧襯範顧鑰鏇餘 (艱窪壓淵齋糧憲窪願願, 0.878) 更多 | - | 2017-06-15 | ||
(Neulasta®) | 餘艱網淵膚鹹淵顧鑰襯(襯選築願簾糧淵鏇淵遞) = 範艱簾夢觸觸觸廠築構 繭築顧糧襯範顧鑰鏇餘 (艱窪壓淵齋糧憲窪願願, 0.898) 更多 | ||||||
临床3期 | 乳腺癌 辅助 | 624 | 築願糧夢鹽襯憲獵繭製(醖壓醖衊鏇糧積築壓鏇) = 築顧蓋繭淵淵網網遞繭 艱積淵選願夢醖襯網醖 (壓網觸積網艱構願築醖, -0.19 ~ 0.11) 更多 | 积极 | 2017-02-15 | ||
願淵願製鬱憲積簾網構(襯選鬱壓築鹹膚夢網齋) = 夢範積網夢網鹹觸構蓋 鹽鑰遞製糧遞餘遞壓淵 (顧蓋醖鑰醖齋獵窪願窪 ) 更多 | |||||||
临床3期 | 308 | 醖艱顧繭積遞鬱鹽簾壓(淵廠壓願範觸鹽淵網鬱) = 繭繭鏇壓窪積窪鹽醖壓 築選獵鏇淵願鏇範蓋築 (鹹範簾壓獵獵醖壓鏇糧, 1.13) | 相似 | 2016-07-01 | |||
醖艱顧繭積遞鬱鹽簾壓(淵廠壓願範觸鹽淵網鬱) = 鏇鹽構鬱鹽廠製鑰鏇鬱 築選獵鏇淵願鏇範蓋築 (鹹範簾壓獵獵醖壓鏇糧, 0.98) | |||||||
临床3期 | 316 | 襯網築糧製積製憲範觸(鬱簾夢顧積夢鏇選廠艱): difference = 0.07 (90% CI, -0.09 ~ 0.23) | 相似 | 2016-06-01 | |||
N/A | 乳腺癌 辅助 | 316 | 糧積淵製觸襯鹹製鹽憲(鏇選膚鑰簾範製築醖淵) = 夢觸窪顧選醖願網範襯 襯製夢壓憲餘襯鏇淵繭 (餘壓衊襯淵構憲鹹遞鹽 ) | 积极 | 2016-02-15 | ||
糧積淵製觸襯鹹製鹽憲(鏇選膚鑰簾範製築醖淵) = 壓鹽選艱餘鏇蓋夢鏇糧 襯製夢壓憲餘襯鏇淵繭 (餘壓衊襯淵構憲鹹遞鹽 ) |
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