A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB15 (Proposed Aflibercept Biosimilar) and Eylea® in Subjects With Neovascular Age-related Macular Degeneration

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, Pharmacokinetics (PK), and immunogenicity of SB15 compared to Eylea® in subjects with neovascular AMD.

开始日期2020-06-23

申办/合作机构

Samsung Bioepis Co., Ltd.

EUCTR2019-003883-28-CZ / Not yet recruiting临床3期

A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity between SB15 (proposed aflibercept biosimilar) and Eylea® in Subjects with Neovascular Age-related Macular Degeneration

开始日期2020-05-07

申办/合作机构

Samsung Bioepis Co., Ltd.

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项与阿柏西普生物类似药 (Samsung Bioepis) 相关的文献（医药）

2023-12-01·BMJ open ophthalmology

Biosimilar SB15 versus reference aflibercept in neovascular age-related macular degeneration: 1-year and switching results of a phase 3 clinical trial

Article

作者: Oh, Inkyung ; Oh, Inkyung ; Ernest, Jan ; Csutak, Adrienne ; Yun, Cheolmin ; Studnička, Jan ; Wylegala, Edward ; Enyedi, Lajos ; Tóth-Molnár, Edit ; Vajas, Attila ; Patel, Sunil ; Jang, Hyerin ; Sadda, SriniVas R ; Choi, Wooree ; Veith, Miroslav ; Woo, Se Joon ; Bradvica, Mario ; Sagong, Min ; Orski, Michal ; Astakhov, Sergei

Background/aims:

To evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of SB15 versus reference aflibercept (AFL), and switching from AFL to SB15 in neovascular age-related macular degeneration (nAMD).

Design:

Prospective, double-masked, randomised, phase 3 trial.

Methods:

Participants with nAMD were randomised 1:1 to receive SB15 (N=224 participants) or AFL (N=225). At week 32, participants either continued on SB15 (SB15/SB15, N=219) or AFL (AFL/AFL, N=108), or switched from AFL to SB15 (AFL/SB15, N=111). This manuscript reports 1-year and switching results of secondary efficacy endpoints such as changes from baseline to week 56 in best-corrected visual acuity (BCVA), central subfield thickness (CST, from internal limiting membrane (ILM) to retinal pigment epithelium), and total retinal thickness (TRT, from ILM to Bruch’s membrane). Additional endpoints included safety, PK and immunogenicity.

Results:

Efficacy results were comparable between groups. The least squares mean (LSmean) change in BCVA from baseline to week 56 was 7.4 letters for SB15/SB15 and 7.0 letters for AFL/AFL (difference (95% CI)=0.4 (−2.5 to 3.2)). The LSmean changes from baseline to week 56 in CST and TRT were −119.2 µm and −132.4 µm for SB15/SB15 and −126.6 µm and −136.3 µm for AFL/AFL, respectively (CST: difference (95% CI)=7.4 µm (−6.11 to 20.96); TRT: difference (95% CI)=3.9 µm (−18.35 to 26.10)). Switched and non-switched participants showed similar LSmean changes in BCVA from baseline to week 56 (AFL/SB15, 7.9 letters vs AFL/AFL, 7.8 letters; difference (95% CI)=0.0 (−2.8 to 2.8)). Safety, PK and immunogenicity were comparable between groups.

Conclusions:

Efficacy, safety, PK and immunogenicity were comparable between SB15 and AFL and between switched and non-switched participants.

2023-07-01·JAMA ophthalmology

Efficacy and Safety of the Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular Degeneration: A Phase 3 Randomized Clinical Trial.

Article

作者: Oh, Inkyung ; Kim, Taehyung ; Csutak, Adrienne ; Yun, Cheolmin ; Ernest, Jan ; Vajas, Attila ; Jang, Hyerin ; Tóth-Molnár, Edit ; Enyedi, Lajos ; Patel, Sunil ; Wylegala, Edward ; Sadda, SriniVas R ; Veith, Miroslav ; Woo, Se Joon ; Astakhov, Sergei ; Studnicka, Jan ; Sagong, Min ; Orski, Michal ; Bradvica, Mario

Importance:

Aflibercept biosimilars can expand available treatment options in retinal diseases and have the potential to improve patient access to safe and effective therapy.

Objective:

To establish equivalence in efficacy and similarity in safety, pharmacokinetics, and immunogenicity of SB15 and reference aflibercept (AFL) in neovascular age-related macular degeneration (nAMD).

Design, Setting, and Participants:

This was a randomized double-masked parallel group phase 3 trial conducted at 56 centers in 10 countries from June 2020 to March 2022, including follow-up through 56 weeks. Of 549 screened participants, 449 participants 50 years and older with treatment-naive nAMD were included and randomly assigned to SB15 (n = 224) or AFL (n = 225). Key exclusion criteria included considerable scarring, fibrosis, atrophy, and hemorrhage. This report includes results up to the end of the parallel group period at week 32. Of the 449 randomized participants, 438 (97.6%) completed week 32 follow-up.

Intervention:

Participants were randomized 1:1 to receive 2 mg of SB15 or AFL every 4 weeks for the first 12 weeks (3 injections), followed by dosing every 8 weeks up to week 48, with final assessments at week 56.

Main Outcomes and Measures:

The primary end point was the change in best-corrected visual acuity (BCVA) from baseline to week 8 with predefined equivalence margins of -3 letters to 3 letters. Other key end points were changes in BCVA and central subfield thickness up to week 32, safety, pharmacokinetics, and immunogenicity.

Results:

The mean (SD) age among the 449 included participants was 74.0 (8.1) years, and 250 participants (55.7%) were female. Baseline demographic characteristics and most disease characteristics were comparable between treatment groups. The least squares mean change in BCVA from baseline to week 8 in the SB15 group was equivalent to that in the AFL group (6.7 letters vs 6.6 letters, respectively; difference, 0.1 letters; 95% CI, -1.3 to 1.4). Comparable efficacy between treatment groups was maintained up to week 32 (least squares mean change from baseline in BCVA: SB15, 7.6 letters vs AFL, 6.5 letters; least squares mean change from baseline in central subfield thickness: SB15, -110.4 μm vs AFL, -115.7 μm). No clinically relevant differences were observed in the incidence of treatment-emergent adverse events (TEAEs) (SB15, 107/224 [47.8%] vs AFL, 98/224 [43.8%]) and ocular TEAEs in the study eye (SB15, 41/224 [18.3%] vs AFL, 28/224 [12.5%]). The serum concentration profiles and cumulative incidences of overall antidrug antibody positive participants were comparable.

Conclusions and Relevance:

In this phase 3 randomized clinical trial, SB15 and AFL showed equivalent efficacy and comparable safety, pharmacokinetics, and immunogenicity in participants with nAMD.

Trial Registration:

ClinicalTrials.gov Identifier: NCT04450329.

2023-06-01·Materials today. Chemistry

COVID-19 impedimetric biosensor based on polypyrrole nanotubes, nickel hydroxide and VHH antibody fragment: specific, sensitive, and rapid viral detection in saliva samples.

Article

作者: Hiraiwa, P M ; Baêta Rodrigues, D S ; Zanchin, N I T ; Macedo de Souza Brandão, A P ; Deller, A E ; Guimarães, B G ; Vidotti, M ; Hryniewicz, B M ; Soares, F L F ; Camargo de Oliveira, C ; Schuster da Silva, S ; Bach-Toledo, L ; Santos, A ; Abreu, H ; Gradia, D F ; Marchesi, L F ; Carvalho de Oliveira, J ; Rogerio, V Z

SARS-CoV-2 rapid spread required urgent, accurate, and prompt diagnosis to control the virus dissemination and pandemic management. Several sensors were developed using different biorecognition elements to obtain high specificity and sensitivity. However, the task to achieve these parameters in combination with fast detection, simplicity, and portability to identify the biorecognition element even in low concentration remains a challenge. Therefore, we developed an electrochemical biosensor based on polypyrrole nanotubes coupled via Ni(OH)₂ ligation to an engineered antigen-binding fragment of heavy chain-only antibodies (VHH) termed Sb#15. Herein we report Sb#15-His6 expression, purification, and characterization of its interaction with the receptor-binding domain (RBD) of SARS-CoV-2 in addition to the construction and validation of a biosensor. The recombinant Sb#15 is correctly folded and interacts with the RBD with a dissociation constant (K_D) of 27.1 ± 6.4 nmol/L. The biosensing platform was developed using polypyrrole nanotubes and Ni(OH)₂, which can properly orientate the immobilization of Sb#15-His6 at the electrode surface through His-tag interaction for the sensitive SARS-CoV-2 antigen detection. The quantification limit was determined as 0.01 pg/mL using recombinant RBD, which was expressively lower than commercial monoclonal antibodies. In pre-characterized saliva, both Omicron and Delta SARS-CoV-2 were accurately detected only in positive samples, meeting all the requirements recommended by the World Health Organization for in vitro diagnostics. A low sample volume of saliva is needed to perform the detection, providing results within 15 min without further sample preparations. In summary, a new perspective allying recombinant VHHs with biosensor development and real sample detection was explored, addressing the need for accurate, rapid, and sensitive biosensors.

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·CPHI制药在线

康方生物PD-1/VEGF双抗依沃西获批上市治疗肺癌；盛禾生物在港交所正式上市 | 制药在线一周药闻复盘

点击蓝字关注我们本周，热点很多，值得重点关注。首先是审评审批方面，有不少创新药获批，重点说4个，倍而达的1类新药甲磺酸瑞齐替尼胶囊、再鼎引进的1类新药注射用舒巴坦钠/注射用度洛巴坦钠组合包装、海思科的1类新药苯磺酸克利加巴林胶囊以及康方生物的PD-1/VEGF双抗依沃西单抗注射液；其次是研发方面，不少药研发取得进展，其中值得一提的就是，正大天晴PD-L1组合一线治疗肾细胞癌Ⅲ期研究结果积极，即将递交上市申请；再次是交易及投融资方面，达歌生物与武田合作开发分子胶药物，总交易额达12亿美元；最后是上市方面，盛禾生物在港交所正式上市。本周盘点包括审评审批、研发、交易及投融资以及上市四大板块，统计时间为5.20-5.24，包含28条信息。审评审批NMPA上市批准1、5月20日，NMPA官网显示，倍而达的1类新药甲磺酸瑞齐替尼胶囊（商品名：瑞必达）获批上市，用于治疗既往经表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗时或治疗后出现疾病进展，并且经检测确认存在EGFR T790M突变阳性局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。瑞齐替尼是一款不可逆、高选择性第三代小分子EGFR-TKI。2、5月20日，NMPA官网显示，Entasis Therapeutics的1类新药注射用舒巴坦钠/注射用度洛巴坦钠组合包装（商品名：鼎优乐）（再鼎引进）获批上市，用于治疗18岁及以上患者由鲍曼-醋酸钙不动杆菌复合体（ABC）敏感分离株所致医院获得性细菌性肺炎（HABP）、呼吸机相关性细菌性肺炎（VABP）。舒巴坦是一种β-内酰胺类抗菌药物和Ambler A类丝氨酸β-内酰胺酶抑制剂，度洛巴坦是一种二氮杂二环辛烷、非β-内酰胺类的β-内酰胺酶抑制剂。3、5月20日，NMPA官网显示，海思科的1类新药苯磺酸克利加巴林胶囊（HSK16149、商品名：思美宁）获批上市，用于治疗成人糖尿病性周围神经病理性疼痛。HSK16149胶囊是一款抑制性神经递质γ-氨基丁酸（GABA）的结构衍生物。此前，HSK16149用于带状疱疹后遗神经痛的新适应症上市申请已于2023年9月获NMPA受理，目前正在审评中。4、5月21日，NMPA官网显示，礼来的替尔泊肽注射液（Tirzepatide、Mounjaro）获批上市，用于改善成人2型糖尿病患者的血糖控制。Tirzepatide是一款每周注射一次的葡萄糖依赖性促胰岛素多肽（GIP）和胰高血糖素样肽-1（GLP-1）受体双重激动剂。目前，Tirzepatide减重适应症上市申请已获NMPA受理，正在审评中。5、5月21日，NMPA官网显示，信立泰的阿利沙坦酯氨氯地平片（SAL0107）获批上市，用于治疗阿利沙坦酯或氨氯地平单药治疗后血压控制不佳的原发性高血压患者。SAL0107是一款血管紧张素Ⅱ受体拮抗剂（ARB）/钙通道阻滞（CCB）复方制剂，属于国内进展较快的ARB/CCB类降压药。6、5月21日，NMPA官网显示，恒瑞医药的氟唑帕利胶囊新适应症获批，用于晚期上皮性卵巢癌、输卵管癌或原发性腹膜癌患者在一线含铂化疗达到完全缓解或部分缓解后的维持治疗。氟唑帕利是恒瑞医药研发的一种新型口服PARP抑制剂，可特异性杀伤BRCA突变的肿瘤细胞。7、5月22日，NMPA官网显示，复宏汉霖的阿达木单抗注射液（商品名：汉达远）新适应症获批，用于治疗多关节型幼年特发性关节炎、儿童斑块状银屑病、克罗恩病和儿童克罗恩病四项适应症。此前，该产品已获NMPA批准治疗类风湿关节炎、强直性脊柱炎、银屑病和葡萄膜炎。8、5月24日，NMPA官网显示，康方生物的依沃西单抗注射液（商品名：依达方、AK112）通过优先审评审批程序获批上市，联合培美曲塞和卡铂，治疗经表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）治疗后进展的EGFR基因突变阳性的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）患者。AK112是一种靶向结合VEGF-A和PD-1的IgG1亚型人源化双特异性抗体。申请9、5月21日，CDE官网显示，信达生物的替妥尤单抗注射液（研发代号：IBI311）申报上市，用于甲状腺眼病（Thyroid Eye Disease，TED）的治疗。替妥尤单抗是一款重组抗胰岛素样生长因子1（IGF-1R）抗体。10、5月22日，CDE官网显示，赛诺菲的2.2类治疗用生物制品艾沙妥昔单抗注射液新适应症申报上市，结合此前赛诺菲公布的Ⅲ期IMROZ试验结果，推测一线治疗不符合移植条件的多发性骨髓瘤（MM）患者。艾沙妥昔单抗靶向多发性骨髓瘤细胞上CD38受体的特异性表位，可触发多种不同的作用机制，包括程序性肿瘤细胞死亡（凋亡）和机体免疫反应调节。11、5月24日，CDE官网显示，复星医药的复迈替尼片（FCN-159）申报上市，用于治疗成人树突状细胞和组织细胞肿瘤，此前该适应症已被纳入优先审评程序。复迈替尼是复星医药自主研发的小分子MEK1/2选择性抑制剂，拟主要用于晚期实体瘤、Ⅰ型神经纤维瘤、树突状细胞和组织细胞肿瘤、低级别脑胶质瘤等的治疗。临床批准 12、5月21日，CDE官网显示，宜联生物的1类新药注射用YL205获批临床，拟开发治疗晚期实体瘤。YL205是全球范围内较早一批进入到临床研究阶段的靶向NaPi2b的ADC。NaPi2b是一种细胞表面钠依赖性磷酸盐转运蛋白。13、5月21日，CDE官网显示，百极优棠的1类新药BPYT-01胶囊获批临床，拟开发用于超重和肥胖。BPYT-01是一款口服小分子GLP-1促泌剂，此前其针对2型糖尿病的临床试验申请已获得CDE批准，并已经完成Ⅰ期临床研究首剂量入组。14、5月22日，CDE官网显示，罗氏（Roche）旗下基因泰克（Genentech）公司的1类新药Vixarelimab注射液获批临床，拟用于治疗溃疡性结肠炎。Vixarelimab（RG6536）是一款潜在“first-in-class”阻断OSMRβ的全人源单克隆抗体，目前在国际上处于Ⅱ期临床阶段。突破性疗法15、5月21日，CDE官网显示，恒瑞医药的注射用SHR-A1921拟纳入突破性治疗品种，针对适应症为铂耐药复发上皮性卵巢癌、输卵管癌或原发性腹膜癌。这是其自主研发的靶向TROP-2的ADC，此前该药治疗铂耐药复发上皮性卵巢癌已经被美国FDA授予快速通道资格。16、5月22日，CDE官网显示，荣昌生物的注射用维迪西妥单抗拟纳入突破性治疗品种，联合特瑞普利单抗注射液围手术期治疗存在HER2表达且计划进行根治性膀胱切除术的肌层浸润性膀胱癌。维迪西妥单抗是荣昌生物研发的HER2 ADC，目前已有胃癌、尿路上皮癌两大适应症获批上市。优先审评17、5月20日，CDE官网显示，复星医药的FCN-159片拟纳入优先审评，拟用于治疗2岁及2岁以上儿童1型神经纤维瘤病（NF1）相关的丛状神经纤维瘤（PN）。FCN-159是一款口服选择性MEK1/2抑制剂。18、5月22日，CDE官网显示，信达生物的替妥尤单抗注射液拟被纳入优先审评，用于治疗甲状腺眼病。替妥尤单抗（研发代号：IBI311）是其开发的一款重组抗胰岛素样生长因子1受体（IGF-1R）抗体。FDA上市批准19、5月20日，FDA官网显示，Biocon的aflibercept-jbvf（Yesafili）和Samsung Bioepis/渤健的aflibercept-yszy（Opuviz）获批上市，均以2mg注射液的形式进行玻璃体内给药（眼内注射），这也是首次获FDA批准的阿柏西普生物类似药。阿柏西普原研由再生元和拜耳共同开发，可同时阻断VEGF-A、VEGF-B以及PIGF，作用靶点更广，可更有效地结合VEGF二聚体。突破性疗法20、5月21日，FDA官网显示，罗氏的Inavolisib被授予突破性疗法认定，通过与哌柏西利（palbociclib）和氟维司群（fulvestrant）联合使用，用于治疗PIK3CA突变、激素受体阳性（HR+）、人表皮生长因子受体2阴性（HER2-）、在完成辅助内分泌治疗后或12个月内复发的局部晚期或转移性乳腺癌成年患者。Inavolisib是一款口服、高选择性PI3Kα抑制剂。快速通道资格21、5月21日，FDA官网显示，中美瑞康（Ractigen Therapeutics）的RAG-01被授予快速通道资格，用于治疗卡介苗无应答的非肌层浸润性膀胱癌。RAG-01是一款特异性靶向激活肿瘤抑制基因p21的双链saRNA药物，通过RNAa机制激活p21基因的表达，以抑制肿瘤细胞增殖、诱导细胞凋亡和衰老。EMA上市批准22、5月22日，EMA官网显示，山德士（Sandoz）的地舒单抗生物类似药Wyost和Jubbonti获批上市，这两款药物分别是安进的Xgeva和Prolia在欧洲的首个也是目前唯一获批的生物类似药版本。Wyost被批准用于治疗癌症相关骨病，Jubbonti被批准用于治疗骨质疏松症。山德士预计从2025年11月开始销售这两款药物。研发临床状态23、5月22日，药物临床试验登记与信息公示平台显示，恒瑞医药登记了一项随机对照、开放性、多中心Ⅲ期研究（登记号：CTR20241861），旨在评估SHR-A1811对比卡瑞利珠单抗联合含铂双药化疗一线治疗HER2突变的晚期或转移性非小细胞肺癌（NSCLC）患者的安全性和有效性。SHR-A1811是恒瑞医药自主研发的一款HER2 ADC。24、5月23日，药物临床试验登记与信息公示平台显示，Karuna启动了一项评价KarXT治疗阿尔茨海默病相关的精神行为症状的国际多中心（含中国）Ⅲ期临床研究。KarXT是一种潜在“first-in-class”毒蕈碱类抗精神病药物，再鼎医药拥有KarXT在大中华区（包括中国内地、香港、澳门和台湾地区）的开发、生产和商业化权益。临床数据25、5月22日，赛诺菲公布了BTK抑制剂Rilzabrutinib治疗中重度哮喘的Ⅱ期研究数据。结果显示，治疗第12周时，高剂量和低剂量Rilzabrutinib组患者的LOAC事件次数相比安慰剂组分别降低了36%和25%，并且显著缓解了患者的哮喘症状。目前尚未有BTK抑制剂在哮喘适应症上推进至Ⅲ期阶段。26、5月23日，正大天晴公布了PD-L1单抗贝莫苏拜单抗联合TKI抑制剂安罗替尼用于晚期不可切除或转移性肾细胞癌（RCC）一线治疗的Ⅲ期临床的主要研究终点无进展生存期（PFS，基于独立影像评估）达到方案预设的优效界值，且次要终点总生存期（OS）显示获益趋势。该公司将于近期递交该适应症的上市申请。交易及投融资27、5月23日，达歌生物宣布，与武田（Takeda）达成多靶点合作研发及独家许可协议，以发现和开发用于肿瘤学、神经科学和炎症领域多个靶点的新型分子胶降解剂。根据协议，达歌生物将利用其GlueXplorer平台，针对武田选定的特定疾病靶点发现、验证和优化分子胶降解剂。达歌生物将获得首付款和潜在里程碑共计最高可达12亿美元。同时，武田也会对达歌生物进行股权投资。上市28、5月24日，盛禾生物在港交所正式上市。盛禾生物成立于2018年，是一家临床阶段生物医药公司，专注于发现、开发和商业化用于治疗癌症和自身免疫性疾病的生物制剂。该公司研发管线中包括了9种创新产品，涵盖单抗、双抗和抗体细胞因子药物等，进展最快的产品已经进入Ⅱ/Ⅲ期临床研究阶段。【企业推荐】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

上市批准临床3期优先审批申请上市

2024-05-22

·BioPharmaDive

Regeneron faces new biosimilar threats; an AI biotech lays off staff

BioPharma Dive is testing out a new format rounding up smaller updates from around the industry. Have thoughts on what could make this type of story better? Drop us a line!Today, a brief rundown of news from Boehringer Ingelheim, as well as notes on GSK, Bristol Myers Squibb, Exscientia and Regeneron that you may have missed earlier this week:Boehringer Ingelheimhas expandedan existing deal with OSE Immunotherapeutics, the companies said Wednesday. The partners will now evaluate a pair of cancer drug prospects as cardiometabolic therapies, with a Phase 2 study scheduled to start later this year. Theyre also starting a preclinical cancer immunotherapy program. OSE will receive 13.5 million upfront, another 17.5 million in the near term, and possibly an additional 1.1 billion in future payouts. Ben FidlerA long-acting asthma drug being developed by GSK succeeded in a pair of Phase 3 trials that enrolled adults and adolescents with a severe form of the breathing condition. Treatment with the drug, an antibody called depemokimab, significantly reduced the annualized rate of asthma attacks over one year, compared to a placebo, the company said Tuesday. GSK is testing a six-month dosing schedule, or two injections per year. Ned PagliaruloBristol Myers Squibb now expects an FDA approval decision on its subcutaneous formulation of Opdivo by Dec.29, rather than the Feb. 28, 2025 date it originally announced. The under-the-skin shot, which is co-formulated with recombinant human hyaluronidase made by Halozyme, is under review for all adult, solid tumor indications for which Opdivo is currently approved. Ned PagliaruloExscientia, a specialist in AI-powered drug discovery, on Tuesday said it would lay off between 20% and 25% of its workforce by the end of the year. The cuts are part of efficiency measures designed to save costs and simplify operations, the company said. Exscientia, which fired its CEO in March, employed 483 staff at the end of last year. Ned PagliaruloThe Food and Drug Administration on Monday approved two biosimilar versions of Regenerons blockbuster eye disease drug Eylea. Both are cleared for interchangeable use, meaning a pharmacist can substitute them for Eylea without first consulting the prescribing physician. Dubbed Yesafili and Opuviz, the biosimilars will be marketed in the U.S. by Biocon Biologics and Biogen, respectively, although its unclear exactly when they might be able to launch due to ongoing patent litigation. Ned Pagliarulo '

临床3期免疫疗法临床结果临床2期上市批准

2024-05-21

·BioSpace

FDA Greenlights Two Interchangeable Biosimilars to Regeneron’s Eylea

Pictured: FDA signage at its office in Maryland/iStock, hapabapa The FDA on Monday approved two biosimilars to Regeneron Pharmaceuticals’ blockbuster eye injection Eylea (aflibercept)—Biocon Biologics’ Yesafili (aflibercept-jbvf) and Samsung Bioepis and Biogen’s Opuviz (aflibercept-yszy). Yesafili and Opuviz also have the FDA’s interchangeability designation, which means they may be used in place of the reference branded product without needing to consult the prescriber, according to the FDA’s announcement. It is not yet clear when the two biosimilars will launch in the U.S. and what their list prices will be, though Biocon has announced that Yesafili will be available in Canada no later than July 1, 2025, under a settlement agreement. Like the reference product, Yesafili and Opuviz are designed to be administered via an intravitreal injection and are indicated for wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic retinopathy and diabetic macular edema. Monday’s approval follows the FDA’s comprehensive review of data showing that Yesafili and Opuviz are “highly similar to Eylea” and that the biosimilars show “no clinically meaningful differences.” These data include physicochemical and biological tests, which confirmed that the biosimilars were structurally and functionally similar to Eylea, according to the regulator. The FDA also reviewed comparative clinical data, showing that the biosimilars did not differ from Eylea in terms of efficacy, safety and immunogenicity. The reference product Eylea is a soluble decoy receptor that binds both the VEGF-A and PIGF ligands, preventing them from activating their corresponding receptors. This mechanism of action allows Eylea to prevent the abnormal growth of blood vessels in the eyes. While Eylea is exclusively commercialized by Regeneron in the U.S., it is partnered with Bayer outside the country with profits shared equally between the companies. The drug was first approved by the FDA in 2011 for the treatment of wet age-related macular degeneration. Since then, it has won several other indications and has become one of Regeneron’s best-performing assets. In 2021, the eye injection brought in $9.2 billion worldwide, increasing to $9.6 billion the following year. However, in 2023, Eylea sales slipped to nearly $9.4 billion primarily due to strong competition from Roche’s Vabysmo (faricimab-svoa). Key patent protections for Eylea are set to expire this year and Regeneron has been fending off would-be competitors with a spate of lawsuits. In December 2023, it won a case against Viatris keeping the biotech’s biosimilar out of the U.S. until 2027. Regeneron also has a case against Samsung Biologics. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

上市批准专利侵权专利到期

100 项与阿柏西普生物类似药 (Samsung Bioepis) 相关的药物交易

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适应症	国家/地区	公司	日期
糖尿病性黄斑水肿	韩国	Samsung Bioepis Co., Ltd.	2024-02-23
近视脉络膜新生血管	韩国	Samsung Bioepis Co., Ltd.	2024-02-23
视网膜静脉阻塞相关黄斑水肿	韩国	Samsung Bioepis Co., Ltd.	2024-02-23
湿性年龄相关性黄斑变性	韩国	Samsung Bioepis Co., Ltd.	2024-02-23

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04450329 (CTgov)	临床3期	湿性年龄相关性黄斑变性	449	SB15 (Proposed aflibercept biosimilar) (SB15 (Proposed Aflibercept Biosimilar))	膚繭遞齋顧築壓獵餘顧(獵顧選窪網襯衊壓網鏇) = 膚壓鑰遞鑰艱積鹽廠膚觸壓遞構壓齋夢襯鹽壓 (願簾壓壓獵齋網範窪襯, 鑰鑰憲蓋夢淵製糧鑰憲 ~ 憲繭顧鏇餘簾鹹壓鹹夢) 更多	-	2024-02-05
				SB15 (Proposed aflibercept biosimilar) (Eylea (Aflibercept))	膚繭遞齋顧築壓獵餘顧(獵顧選窪網襯衊壓網鏇) = 願夢獵淵膚鹹膚觸簾獵觸壓遞構壓齋夢襯鹽壓 (願簾壓壓獵齋網範窪襯, 齋鹽鑰積製鑰淵獵淵鏇 ~ 顧艱獵壓艱構窪網餘齋) 更多
EURETINA2023 人工标引	临床3期	年龄相关性黄斑变性	449	SB15	糧鬱鹽餘築襯醖壓蓋鏇(願廠膚願選繭齋鹹淵鹽) = 構顧積醖壓壓餘餘鬱鏇選鑰簾憲觸齋積廠選範 (廠鏇淵積遞選簾糧鹹鏇 )	相似	2023-10-05
				Aflibercept	糧鬱鹽餘築襯醖壓蓋鏇(願廠膚願選繭齋鹹淵鹽) = 壓齋鏇選淵艱觸鹽繭襯選鑰簾憲觸齋積廠選範 (廠鏇淵積遞選簾糧鹹鏇 )
EURETINA2023 人工标引	临床3期	湿性年龄相关性黄斑变性	438	SB15	範壓選積網範齋鑰選製(襯蓋鑰齋糧顧衊築顧艱) = 壓壓鏇簾艱齋膚糧獵觸窪構鹹獵積襯範糧選鏇 (蓋鑰壓製夢膚夢構衊壓 ) 更多	积极	2023-10-05
				Aflibercept	範壓選積網範齋鑰選製(襯蓋鑰齋糧顧衊築顧艱) = 艱積製構鹽艱衊廠願積窪構鹹獵積襯範糧選鏇 (蓋鑰壓製夢膚夢構衊壓 ) 更多
Phase III Randomized Clinical Trial Comparing SB15 with Reference Aflibercept in Neovascular Age-Related Macular Degeneration (ARVO2023)	临床3期	湿性年龄相关性黄斑变性	449	SB15 2 mg	淵構衊襯顧艱蓋觸築築(艱選願壓鬱餘範襯鏇鹹) = 顧壓憲膚遞範鏇願製積鹹築蓋壓蓋齋襯鑰獵鹹 (衊構觸蓋憲糧網艱窪選 )	积极	2023-06-01
				Aflibercept	淵構衊襯顧艱蓋觸築築(艱選願壓鬱餘範襯鏇鹹) = 選艱顧醖構淵顧壓襯夢鹹築蓋壓蓋齋襯鑰獵鹹 (衊構觸蓋憲糧網艱窪選 )
PO381 (AAO2022)	临床3期	湿性年龄相关性黄斑变性	-	SB15	製襯鬱觸繭淵遞窪膚鏇(鏇膚餘蓋齋廠顧願製鹹) = 願窪膚壓餘遞憲壓構築艱蓋憲選膚蓋齋鬱繭齋 (獵顧遞鏇製獵鑰觸蓋鑰 )	积极	2022-09-29
				Aflibercept	製襯鬱觸繭淵遞窪膚鏇(鏇膚餘蓋齋廠顧願製鹹) = 糧繭窪襯鏇蓋顧遞鬱積艱蓋憲選膚蓋齋鬱繭齋 (獵顧遞鏇製獵鑰觸蓋鑰 )