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更新于：2026-05-07
Bevacizumab biosimilar(Samsung Bioepis Co., Ltd.)
贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.)
更新于：2026-05-07
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2020-08-19), |
最高研发阶段(中国)无进展 |
特殊审评- |
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结构/序列
Sequence Code 41632H
当前序列信息引自: *****
Sequence Code 41637L
当前序列信息引自: *****
关联
2
项与 贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的临床试验NCT02754882
A Phase 3, Randomised, Double-blind Study to Compare the Efficacy, Safety, PK and Immunogenicity Between SB8 (Proposed Bevacizumab Biosimilar) and Avastin® in Subjects With Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer
NCT02453672
A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab (SB8, EU Sourced Avastin®, and US Sourced Avastin®) in Healthy Male Subjects
100 项与 贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的临床结果
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100 项与 贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的转化医学
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100 项与 贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的专利（医药）
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32
项与 贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的文献（医药）2026-01-01JOURNAL OF PEDIATRICS
Increase in Health Care Utilization of Texas Infants with Congenital Anomalies Following Senate Bill 8
Article
作者: Lee, Timothy C ; King, Alice ; Larabee, Shannon M ; Hosek, Kathleen E ; Keswani, Sundeep G ; Guerra, Mary Elizabeth ; Peiffer, Sarah E ; Cheng, Lily S
OBJECTIVE:
To evaluate the impact of Texas Senate Bill 8 (SB8), which bans early abortion, on health care utilization of infants with congenital anomalies.
STUDY DESIGN:
The Texas Inpatient Public Use Data File was queried for inpatient encounters of Texas patients <1 year old between July 1, 2020, and June 30, 2023. Encounters were grouped as pre-SB8 (July 1, 2020-June 30, 2021) and post-SB8 (July 1, 2022-June 30, 2023). Descriptive statistics and bivariate analyses were used to compare rates of congenital anomaly admissions, mortality, length of stay, and hospital charges.
RESULTS:
Among 1 149 242 infant inpatient admissions, 204 580 were for patients with congenital anomalies. Post-SB8, the proportions of anomaly admissions increased from 17.1% to 19.0% (P < .0001). Mortality and length of stay of these admissions remained similar. However, total charges for congenital anomaly admissions increased by $1.89 billion to over $8.7 billion post-SB8 (P < .0001), accounting for 56.5% of all inpatient charges despite comprising a minority of admissions.
CONCLUSIONS:
Following SB8, inpatient admissions and charges for infants with congenital anomalies increased significantly. Although these patients represent a small proportion of admissions, their care accounts for a disproportionate share of hospital costs and increased by $1.89 billion following SB8. Future studies should explore outpatient costs and long-term outcomes following abortion restrictions.
2025-11-01AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY
Association of reproductive access restrictions and out-of-state abortion care in Colorado: an interrupted time series analysis for 2018 to 2024
Article
作者: Neophytou, Andreas M ; Gutilla, Margaret J ; DeBie, Kelly A ; Keller, Kayleigh P ; Peel, Jennifer L
OBJECTIVE:
Access to abortion has changed dramatically in the United States in recent years, both at the federal and state level. For nearly 50 years, the right to abortion was considered a federally protected right under the Roev. Wade (1973) recognition of privacy rights under the 14th Amendment. In September 2021, Texas passed State Bill 8 which implemented a 6-week restriction on access to abortion. The following year, in 2022, the Supreme Court issued the Dobbs v. Jackson Women's Health Organization decision. Dobbs reversed Roe v. Wade and shifted determinations about legal access to the states, several of which already had trigger bans awaiting the potential removal of this constitutional right. To explore how these legal alterations to access are associated with changes in travel into abortion rights-protective states for abortions by residents of abortion-restrictive states, we sought to measure monthly abortion trends. Specifically, our goal is to compare monthly abortion utilization in Colorado by resident status before and after the introduction of abortion access restrictions, while adjusting for overall temporal trends.
STUDY DESIGN:
Utilizing monthly count data for induced abortions from the Colorado Department of Health and Environment from 2018 to 2024, an interrupted time series analysis was used to assess the association between changes in federal and state law and the number of out-of-state patients traveling to Colorado for abortions. Secondary analysis focused specifically on Texas residents. Quasi-Poisson time series regression models adjusted for time in two ways: first, we used a linear time adjustment to account for any long-term trends and second, we used harmonic terms to account for any seasonal variation present in the data.
RESULTS:
Out-of-state residents were over twice as likely to travel to Colorado after Dobbs compared to before: rate ratio (RR), 2.14 (95% confidence interval, 1.54, 2.99; P<.001). Texas residents were over 7 times more likely to travel to Colorado for abortions after the enactment of State Bill 8. Rate ratio, 7.86 (95% confidence interval, 3.30, 20.09, P<.001). Although initial spikes in travel to Colorado, particularly by Texas residents, have shown a gradual reduction over time, these patterns have not returned to baseline. This may indicate a long-term shift in how abortion care is provided and obtained in the United States in the wake of changes in the law.
CONCLUSION:
There has been a substantial increase in the number of patients traveling to Colorado for abortions associated with changes to both federal and state laws, carrying implications for clinicians and patients alike. While some of the initial demand for abortions from out-of-state residents appears to have reduced in Colorado, it has not returned to baseline and may reflect a permanent shift in how and where abortion care is provided.
2025-03-01CONTRACEPTION
The impact of the SB 8 Texas abortion ban on pregnancy duration at time of abortion in a large volume Colorado clinic
Article
作者: Sheeder, Jeanelle ; Dindinger, Eva ; Coleman-Minahan, Kate ; Fang, Nancy Z
OBJECTIVES:
To assess changes in type of abortion, gestational duration, and changes in the proportion of out-of-state residents at a university-affiliated clinic in Denver, Colorado after Texas passed Senate Bill 8 (SB 8) that banned abortion after embryonic cardiac activity can be detected.
STUDY DESIGN:
We reviewed records of all visits of patients obtaining an abortion ≤22 weeks and 6 days gestation between January 2019 and June 2022. We created two time periods: before SB 8 (January 2019-August 2021) and after SB 8 (September 2021-June 2022). We assessed changes in type of abortion, gestational duration, and the proportion of out-of-state residents. We determined the odds of a second-trimester abortion (≥13 weeks and 0 day) after SB 8 using logistic regression models adjusted for gravida, parity, age, and the proportion of out-of-state residents.
RESULTS:
There were 3844 abortions: 2875 before and 969 after SB 8. Second trimester abortions increased from 16.8% to 24.4% for Colorado residents and from 19.5% to 33.5% for out-of-state residents (p < 0.001). The proportion of patients that were Texas residents increased from 1.2% to 17.7% after SB 8 (p < 0.001). The adjusted odds of a second trimester abortion nearly doubled overall (adjusted odds ratio [aOR] 1.86 95% CI 1.55-2.23) and for Colorado residents (aOR,1.76, 95% CI, 1.44-2.16, respectively), and more than doubled for out-of-state residents (aOR, 2.34, 95% CI,1.53-3.59).
CONCLUSIONS:
Laws that ban abortion early in pregnancy delay care and increase abortions occurring later in pregnancy, not only for people forced to seek care out of state, but for residents of states with abortion access.
IMPLICATIONS:
Our data suggests that abortion bans may increase wait times, gestational duration, and force people to travel great distances for care. As more states ban abortion or restrict abortion, surrounding states where abortion is protected may need to meet the needs of those traveling in addition to their in-state residents.
19
项与 贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的新闻（医药）2026-01-18
临床3期生物类似药抗体药物偶联物临床1期临床2期
2026-01-15
100 项与 贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的药物交易
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外链
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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 |
|---|---|---|---|
| 晚期肾细胞癌 | 澳大利亚 | 2024-01-24 | |
| 高级别胶质瘤 | 澳大利亚 | 2024-01-24 | |
| 局部晚期乳腺癌 | 澳大利亚 | 2024-01-24 | |
| 转移性结直肠癌 | 澳大利亚 | 2024-01-24 | |
| 转移性肾细胞癌 | 澳大利亚 | 2024-01-24 | |
| 非鳞状非小细胞肺癌 | 澳大利亚 | 2024-01-24 | |
| 乳腺癌 | 韩国 | 2021-03-10 | |
| 结直肠癌 | 韩国 | 2021-03-10 | |
| 胶质母细胞瘤 | 韩国 | 2021-03-10 | |
| 复发性原发性腹膜癌 | 欧盟 | 2021-01-11 | |
| 复发性原发性腹膜癌 | 冰岛 | 2021-01-11 | |
| 复发性原发性腹膜癌 | 列支敦士登 | 2021-01-11 | |
| 复发性原发性腹膜癌 | 挪威 | 2021-01-11 | |
| 结肠癌 | 欧盟 | 2020-08-19 | |
| 结肠癌 | 冰岛 | 2020-08-19 | |
| 结肠癌 | 列支敦士登 | 2020-08-19 | |
| 结肠癌 | 挪威 | 2020-08-19 | |
| EGFR阳性非鳞状非小细胞肺癌 | 欧盟 | 2020-08-19 | |
| EGFR阳性非鳞状非小细胞肺癌 | 冰岛 | 2020-08-19 | |
| EGFR阳性非鳞状非小细胞肺癌 | 列支敦士登 | 2020-08-19 |
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临床结果
临床结果
适应症
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临床3期 | 763 | (Bevacizumab (Avastin)) | 憲鑰築顧齋獵顧觸鹽壓 = 廠襯網憲淵顧鏇顧製夢 構築蓋範製簾範製遞窪 (餘築網蓋餘製襯蓋鏇壓, 觸夢範艱齋鹹顧壓網襯 ~ 範鹹憲憲鏇鏇膚鏇鹽繭) 更多 | - | 2024-12-16 | ||
(SB8 (A Proposed Bevacizumab Biosimilar)) | 憲鑰築顧齋獵顧觸鹽壓 = 淵餘淵積壓獵簾觸艱廠 構築蓋範製簾範製遞窪 (餘築網蓋餘製襯蓋鏇壓, 鹹選網襯選積衊鹹膚鑰 ~ 願鹹憲製獵衊餘製窪築) 更多 | ||||||
临床3期 | 665 | 構憲淵獵廠衊構鹹網鬱(築醖鑰鹽糧網艱艱壓蓋) = 製構廠餘憲製蓋淵製醖 顧壓鑰簾鹽繭襯淵艱齋 (膚顧蓋顧繭鬱鹽齋積糧 ) | 积极 | 2020-09-17 | |||
構憲淵獵廠衊構鹹網鬱(築醖鑰鹽糧網艱艱壓蓋) = 鹹築鬱鹽願齋壓選齋蓋 顧壓鑰簾鹽繭襯淵艱齋 (膚顧蓋顧繭鬱鹽齋積糧 ) | |||||||
临床3期 | 763 | 鏇願繭遞顧齋憲壓鏇網(選繭憲襯餘鏇構構衊窪): RR = 1.11 (90% CI, 0.975 ~ 1.269) 更多 | 相似 | 2020-08-01 | |||
临床3期 | 763 | 壓顧願鑰獵觸糧夢窪餘(簾築糧積鹹選襯選衊齋) = 餘選顧範構鏇鹽廠鹽範 鹽鹽鑰糧衊製廠膚艱餘 (醖網築積醖衊艱製選艱, [0.975 ~ 1.269]) 更多 | 积极 | 2019-09-28 | |||
壓顧願鑰獵觸糧夢窪餘(簾築糧積鹹選襯選衊齋) = 廠餘淵糧齋壓壓構繭願 鹽鹽鑰糧衊製廠膚艱餘 (醖網築積醖衊艱製選艱 ) 更多 | |||||||
临床1期 | - | 119 | (EU Sourced Avastin®) | 願鏇廠顧繭壓網選遞鹽(範夢範淵鑰鑰鑰遞簾選) = 鏇鬱鬱淵艱繭窪醖齋築 範鹹壓膚網淵鬱構選壓 (蓋網淵願蓋艱範齋範艱, 6221.62) 更多 | - | 2019-06-03 | |
(US Sourced Avastin®) | 願鏇廠顧繭壓網選遞鹽(範夢範淵鑰鑰鑰遞簾選) = 淵製觸壓艱鏇簾夢壓鬱 範鹹壓膚網淵鬱構選壓 (蓋網淵願蓋艱範齋範艱, 5425.14) 更多 |
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