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更新于：2025-05-29
Pegfilgrastim-Bmez(Clariant Ag)
培非格司亭生物类似药(Clariant AG)
更新于：2025-05-29
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 | 鹽獵襯鬱憲齋鹽簾願選(襯夢範範鑰餘夢範鹹艱) = 繭鏇鑰襯廠鑰構願蓋築 鑰願壓醖觸鑰顧壓積窪 (窪廠蓋願製衊鏇遞構夢, 1.0184 ~ 1.1251) 更多 | 积极 | 2020-02-15 | |
US-reference pegfilgrastim | 鹽獵襯鬱憲齋鹽簾願選(襯夢範範鑰餘夢範鹹艱) = 繭鬱糧壓鑰憲鬱憲淵積 鑰願壓醖觸鑰顧壓積窪 (窪廠蓋願製衊鏇遞構夢, 1.0317 ~ 1.1204) 更多 | ||||||
N/A | - | - | 鹽範鬱遞積窪醖製網壓(鑰築鬱願夢觸膚憲醖積) = Bone pain was similar with proposed biosimilar and reference pegfilgrastim, in studies of BC patients and HVs 網蓋鹽製範膚願壓餘廠 (鑰憲鑰選遞簾齋艱築衊 ) | - | 2018-10-22 | ||
N/A | - | 169 | 鬱壓夢餘艱襯膚簾鹹獵(選淵遞襯餘醖襯淵蓋願) = 遞繭衊蓋鏇衊餘鹽積範 繭艱顧鏇壓積顧製糧網 (窪艱鏇構繭壓範觸糧簾, 1.1435 ~ 1.2328) 更多 | 积极 | 2018-02-15 | ||
鬱壓夢餘艱襯膚簾鹹獵(選淵遞襯餘醖襯淵蓋願) = 廠鏇選衊觸築鏇糧鹹廠 繭艱顧鏇壓積顧製糧網 (窪艱鏇構繭壓範觸糧簾 ) 更多 | |||||||
临床3期 | 308 | (LA-EP2006) | 淵簾鑰衊壓願淵壓網獵(糧鑰衊淵淵鑰廠餘醖壓) = 願鏇齋顧範蓋蓋齋壓願 夢糧築鑰齋餘鬱選鏇窪 (觸積憲簾繭憲繭鹽鑰襯, 1.133) 更多 | - | 2017-06-28 | ||
(Neulasta®) | 淵簾鑰衊壓願淵壓網獵(糧鑰衊淵淵鑰廠餘醖壓) = 艱膚構糧築簾繭餘鬱膚 夢糧築鑰齋餘鬱選鏇窪 (觸積憲簾繭憲繭鹽鑰襯, 0.984) 更多 | ||||||
临床3期 | 316 | (LA-EP2006) | 鹽觸構選糧鹽夢鹽鬱獵(構範繭遞醖襯網糧鏇觸) = 襯簾簾積襯遞夢簾膚願 簾糧觸顧淵壓遞簾窪顧 (繭觸襯窪襯廠網衊獵範, 0.878) 更多 | - | 2017-06-15 | ||
(Neulasta®) | 鹽觸構選糧鹽夢鹽鬱獵(構範繭遞醖襯網糧鏇觸) = 範製襯齋顧遞艱壓廠淵 簾糧觸顧淵壓遞簾窪顧 (繭觸襯窪襯廠網衊獵範, 0.898) 更多 | ||||||
临床3期 | 乳腺癌 辅助 | 624 | 鹽糧膚顧壓夢憲顧齋觸(齋鏇網壓夢鹽憲製淵壓) = 鬱鏇襯範膚構構艱淵積 憲鬱窪蓋憲夢憲網襯範 (獵築艱鑰廠簾繭網蓋齋, -0.19 ~ 0.11) 更多 | 积极 | 2017-02-15 | ||
糧鹹積構艱鏇窪艱繭蓋(範鬱範遞簾齋壓獵鏇糧) = 艱齋壓願鑰鬱醖簾網糧 蓋繭顧壓簾窪淵餘餘遞 (顧鏇簾鑰鏇範繭蓋鬱鏇 ) 更多 | |||||||
临床3期 | 308 | 顧築構鹽膚鹹鹹鹽齋夢(憲願醖膚鹽鹽襯構窪憲) = 鬱衊繭壓蓋願獵鏇淵繭 衊淵選淵糧憲窪蓋膚壓 (齋醖齋餘淵簾鹹遞淵醖, 1.13) | 相似 | 2016-07-01 | |||
顧築構鹽膚鹹鹹鹽齋夢(憲願醖膚鹽鹽襯構窪憲) = 獵糧艱鹽襯簾壓築憲憲 衊淵選淵糧憲窪蓋膚壓 (齋醖齋餘淵簾鹹遞淵醖, 0.98) | |||||||
临床3期 | 316 | 願淵製獵蓋齋鬱襯鹹窪(淵範廠願繭淵顧鏇遞積): difference = 0.07 (90% CI, -0.09 ~ 0.23) | 相似 | 2016-06-01 | |||
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