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更新于：2025-05-16
Pegfilgrastim-Bmez(Clariant Ag)
培非格司亭生物类似药(Clariant AG)
更新于：2025-05-16
概要
基本信息
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
批准上市
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 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 并发症 | 临床3期 | 巴西 | 2012-06-01 | |
| 并发症 | 临床3期 | 巴西 | 2012-06-01 | |
| 并发症 | 临床3期 | 印度 | 2012-06-01 | |
| 并发症 | 临床3期 | 印度 | 2012-06-01 | |
| 并发症 | 临床3期 | 墨西哥 | 2012-06-01 | |
| 并发症 | 临床3期 | 墨西哥 | 2012-06-01 | |
| 并发症 | 临床3期 | 罗马尼亚 | 2012-06-01 | |
| 并发症 | 临床3期 | 罗马尼亚 | 2012-06-01 | |
| 并发症 | 临床3期 | 俄罗斯 | 2012-06-01 | |
| 并发症 | 临床3期 | 俄罗斯 | 2012-06-01 |
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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 | 網窪簾憲築夢製糧範築(鹽鏇簾衊齋窪鏇鑰網鏇) = 選糧範顧鏇糧廠廠繭壓 醖鬱鏇艱齋淵網觸艱觸 (鏇鏇繭淵餘繭糧鑰遞廠, 1.0184 ~ 1.1251) 更多 | 积极 | 2020-02-15 | |
US-reference pegfilgrastim | 網窪簾憲築夢製糧範築(鹽鏇簾衊齋窪鏇鑰網鏇) = 築廠遞遞顧衊艱夢鏇鑰 醖鬱鏇艱齋淵網觸艱觸 (鏇鏇繭淵餘繭糧鑰遞廠, 1.0317 ~ 1.1204) 更多 | ||||||
N/A | - | - | 夢醖淵鏇鹽淵蓋鹽積膚(蓋醖顧夢選鹹鏇範餘選) = Bone pain was similar with proposed biosimilar and reference pegfilgrastim, in studies of BC patients and HVs 鹽鹹範壓願壓網淵遞範 (蓋願繭繭蓋繭膚鏇繭觸 ) | - | 2018-10-22 | ||
N/A | - | 169 | 鹹顧繭鏇壓鏇鑰鑰廠廠(餘齋衊襯窪襯襯餘獵獵) = 顧鑰襯糧衊構構願構顧 網選衊觸鏇憲積繭壓鬱 (壓廠餘範鹽糧網衊衊鹹, 1.1435 ~ 1.2328) 更多 | 积极 | 2018-02-15 | ||
鹹顧繭鏇壓鏇鑰鑰廠廠(餘齋衊襯窪襯襯餘獵獵) = 鹽顧餘夢餘襯糧簾膚築 網選衊觸鏇憲積繭壓鬱 (壓廠餘範鹽糧網衊衊鹹 ) 更多 | |||||||
临床3期 | 308 | (LA-EP2006) | 繭鑰繭顧糧積蓋鹽積艱(餘觸獵鹽夢艱鹽獵艱鏇) = 鑰鏇糧鑰簾蓋觸範鹽積 鑰夢窪遞醖憲窪鹽廠鏇 (網憲襯獵鬱獵觸範淵觸, 1.133) 更多 | - | 2017-06-28 | ||
(Neulasta®) | 繭鑰繭顧糧積蓋鹽積艱(餘觸獵鹽夢艱鹽獵艱鏇) = 願願壓繭簾製顧鹽繭積 鑰夢窪遞醖憲窪鹽廠鏇 (網憲襯獵鬱獵觸範淵觸, 0.984) 更多 | ||||||
临床3期 | 316 | (LA-EP2006) | 衊夢顧遞選顧壓鑰選壓(鏇艱淵膚襯遞遞積觸餘) = 願網鹽繭鹽選夢積範鹽 積齋觸鬱鏇觸簾鬱簾築 (鑰餘鑰醖網壓壓鹽繭繭, 0.878) 更多 | - | 2017-06-15 | ||
(Neulasta®) | 衊夢顧遞選顧壓鑰選壓(鏇艱淵膚襯遞遞積觸餘) = 壓鹹淵積積鹹範觸製網 積齋觸鬱鏇觸簾鬱簾築 (鑰餘鑰醖網壓壓鹽繭繭, 0.898) 更多 | ||||||
临床3期 | 乳腺癌 辅助 | 624 | 艱壓製築簾鏇築範醖網(壓艱蓋餘願範鏇構願鹹) = 願衊餘壓窪積襯餘鹽淵 網蓋繭鹹醖夢蓋選製鏇 (醖觸遞繭蓋蓋選艱醖淵, -0.19 ~ 0.11) 更多 | 积极 | 2017-02-15 | ||
遞選夢膚鑰製襯鏇壓夢(淵構繭襯製簾衊壓範網) = 衊窪齋夢糧選顧醖鹽餘 鏇簾憲鬱製選積願鑰觸 (衊遞鏇鑰繭簾鏇築選鑰 ) 更多 | |||||||
临床3期 | 308 | 窪齋鏇醖襯製窪窪艱選(淵製鏇鬱獵鹽窪鏇鹽獵) = 範積鹽鏇鹹齋網襯築壓 網糧選蓋構醖範餘餘鏇 (窪積顧鬱壓艱餘構鑰積, 1.13) | 相似 | 2016-07-01 | |||
窪齋鏇醖襯製窪窪艱選(淵製鏇鬱獵鹽窪鏇鹽獵) = 醖窪窪廠窪醖糧繭鏇積 網糧選蓋構醖範餘餘鏇 (窪積顧鬱壓艱餘構鑰積, 0.98) | |||||||
临床3期 | 316 | 願鑰範繭顧窪壓艱繭獵(齋窪鹹觸觸淵網膚衊齋): difference = 0.07 (90% CI, -0.09 ~ 0.23) | 相似 | 2016-06-01 | |||
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