An Open-label, Single-arm, Multicenter Study in Patients With Neovascular Age-related Macular Degeneration to Evaluate the Safety of SOK583A1 (40 mg/mL), a Proposed Aflibercept Biosimilar Product, Provided in a Vial Kit

This is a single-arm, open-label study where all patients will receive a single injection of SOK583A1 (40 mg/mL) provided in a vial kit at Baseline. The total study duration for the individual participant is approximately 31 days.

开始日期2022-05-16

申办/合作机构

Sandoz Group AG

NCT05161806

/ Completed临床3期

This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet) nAMD, eligible for IVT aflibercept treatment.

开始日期2022-03-11

申办/合作机构

Sandoz Group AG

JPRN-jRCT2031210120

/ Completed临床3期IIT

A 52 week multicenter, randomized, double masked, 2 arm parallel study to compare efficacy, safety and immunogenicity of SOK583A1 to Eylea, administered intravitreally, in patients with neovascular age related macular degeneration

开始日期2021-11-02

申办/合作机构-

100 项与阿柏西普生物类似药 (Sandoz ) 相关的临床结果

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100 项与阿柏西普生物类似药 (Sandoz ) 相关的专利（医药）

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项与阿柏西普生物类似药 (Sandoz ) 相关的文献（医药）

2025-09-01·Clinical Drug Investigation

SDZ-AFL: An Aflibercept Biosimilar

Review

作者: Syed, Yahiya Y

SDZ-AFL (SOK583A1; Afqlir^®) is a biosimilar of the reference intravitreal aflibercept, a vascular endothelial growth factor inhibitor. SDZ-AFL has been approved in the EU for the treatment of the same indications in adults as reference aflibercept: neovascular age-related macular degeneration (nAMD), visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularisation. SDZ-AFL has similar physicochemical and pharmacodynamic properties to those of reference aflibercept, and pharmacokinetic similarity has been demonstrated in patients with nAMD. SDZ-AFL demonstrated clinical efficacy equivalent to that of reference aflibercept in patients with nAMD and was generally well tolerated in this population. The tolerability, safety and immunogenicity profiles of SDZ-AFL were similar to those of reference aflibercept. The role of reference aflibercept in the management of neovascular retinal diseases is well established, and SDZ-AFL provides an effective biosimilar alternative for patients requiring ophthalmic aflibercept therapy.

2025-01-01·CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL

Development of Biosimilar Aflibercept SDZ-AFL

Review

作者: Alliger, Peter ; Wersig, Cornelia ; Allmannsberger, Lisa ; Silva, Rufino ; Heyn, Jens ; Dodeller, Francis ; Urosevic, Dragan

Purpose:

Aflibercept is a recombinant fusion protein that binds with high affinity to vascular endothelial growth factor A (VEGF-A), and other growth factors, reducing pathological neovascularization and abnormal vascular permeability. Aflibercept is approved as a first-line treatment for several retinal diseases, including neovascular age-related macular degeneration (nAMD); however, the high costs of these biologic agents can impede patient access. In 2024, Sandoz biosimilar aflibercept (SDZ-AFL; SOK583A1, Enzeevu/Afqlir) was approved by the US Food and Drug Administration and the European Medicines Agency as a biosimilar of reference aflibercept (Ref-AFL; Eylea, a trademark of Bayer AG and in the US of Regeneron Pharmaceuticals, Inc) based on a comprehensive package of data.

Methods:

This narrative review summarizes the totality of evidence demonstrating biosimilarity between SDZ-AFL and Ref-AFL, including physicochemical and biological characterization data from analytical in vitro studies, results of an ocular pharmacokinetic (PK) study in rabbits, and clinical efficacy, safety, immunogenicity, and systemic PK data from Phase III clinical studies.

Results:

Analytical evaluation demonstrated that SDZ-AFL has structural homology with Ref-AFL, including identical amino acid sequences, indistinguishable higher-order structures, and highly similar levels of structural variants. SDZ-AFL and Ref-AFL also demonstrated highly similar in vitro biologic activities, including target binding affinity, and potency in terms of neutralization of VEGF-A. In a single-dose ocular PK study in rabbits, vitreal exposure was comparable between SDZ-AFL and Ref-AFL after intravitreal administration. A 52-week Phase III clinical study (Mylight) evaluated the efficacy, safety, immunogenicity, and systemic PK of SDZ-AFL and Ref-AFL in 484 participants with nAMD. The primary endpoint was mean change from baseline to week 8 in best corrected visual acuity (BCVA): the difference between the SDZ-AFL and Ref-AFL groups in this endpoint was -0.3 letters (90% CI -1.5 to 1.0), which met predefined bioequivalence margins. Secondary efficacy endpoints, including changes from baseline in BCVA and central subfield foveal thickness over the whole 52-week study, were also similar for SDZ-AFL and Ref-AFL. Two subsequent "in-use" studies confirmed the safe use of SDZ-AFL provided in either a vial kit or a prefilled syringe.

Conclusion:

This comprehensive totality of evidence has established biosimilarity between SDZ-AFL and Ref-AFL based on comparable physicochemical and biological characteristics, as well as similarity in clinical efficacy, safety, and immunogenicity. The introduction of aflibercept biosimilars to the market is anticipated to reduce barriers to access, potentially increasing the number of appropriate patients with retinal diseases benefiting from this biologic therapy.

2024-10-01·RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES

EFFICACY AND SAFETY OF THE PROPOSED BIOSIMILAR AFLIBERCEPT, SDZ-AFL, IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

Article

作者: Wolf, Armin ; Cen, Liyi ; Dodeller, Francis ; Bordon, Arnaldo F. ; Allmannsberger, Lisa ; Kaiser, Peter K. ; Heyn, Jens ; Urosevic, Dragan ; Silva, Rufino

Purpose::

The Phase 3 Mylight study was designed to confirm clinical equivalence of proposed biosimilar aflibercept (SOK583A1; Sandoz [proposed biosimilar aflibercept, SDZ-AFL]) to its reference biologic (Eylea; Regeneron Pharmaceuticals, Inc; Bayer AG [reference aflibercept, Ref-AFL]).

Method::

Mylight was a prospective, double-masked, 2-arm, parallel Phase 3 study. Participants with neovascular age-related macular degeneration were randomized 1:1 to receive eight injections of SDZ-AFL (n = 244) or Ref-AFL (n = 240) over 48 weeks. The primary endpoint was mean change in best-corrected visual acuity score from baseline to Week 8. Secondary endpoints included anatomical outcomes, best-corrected visual acuity at Weeks 24 and 52, safety, and pharmacokinetics.

Results::

Similarity in mean change in best-corrected visual acuity score was established between SDZ-AFL (n = 235) and Ref-AFL (n = 226) at Week 8 (difference: −0.3 [90% CI, −1.5 to 1.0]) and Week 52. No clinically meaningful differences occurred between groups in anatomical outcomes. Safety profiles were similar, with comparable incidences of treatment-related adverse events (SDZ-AFL: 2.5%; Ref-AFL: 2.9%). The incidence of anti-drug antibodies was similar between groups. Systemic free aflibercept concentrations 24 hours postdose were low and comparable between SDZ-AFL and Ref-AFL.

Conclusion::

Proposed biosimilar aflibercept matched reference aflibercept in efficacy, safety, and pharmacokinetics in participants with neovascular age-related macular degeneration. Therefore, this Phase 3 study confirmed biosimilarity of SDZ-AFL to Ref-AFL.

项与阿柏西普生物类似药 (Sandoz ) 相关的新闻（医药）

2025-11-26

·动脉网

山德士在欧洲推出Afqlir®（阿柏西普），为视网膜疾病患者提供更实惠的选择Sandoz Launches Afqlir® (aflibercept) in Europe, Offering a More Affordable Option for Patients with Retinal Diseases

Sandoz has introduced Afqlir® (aflibercept) in Europe, expanding access to treatment for adults with various retinal diseases. The product, supplied as a 2 mg vial kit and a pre-filled syringe for intravitreal injection, received European Commission approval in November 2024. Afqlir® is authorised for the same uses as the reference medicine Eylea®, including the treatment of several retinal conditions that can lead to vision loss. 山德士在欧洲推出了Afqlir®（阿柏西普），扩大了成人各种视网膜疾病的治疗可及性。该产品以2毫克小瓶套装和预填充注射器形式供应，用于玻璃体内注射，并于2024年11月获得欧盟委员会批准。Afqlir®被授权的用途与参考药物Eylea®相同，包括治疗可能导致视力丧失的多种视网膜疾病。Clinical studies have shown that Afqlir® matches the reference product in terms of efficacy, safety and pharmacokinetics.. 临床研究表明，Afqlir® 在有效性、安全性和药代动力学方面与参照产品相匹配。Aflibercept is widely regarded as a key treatment for neovascular retinal diseases. Conditions such as age-related macular degeneration (AMD), retinal vein occlusion and diabetic macular oedema are among the main causes of vision impairment worldwide, with the number of affected patients continuing to grow.. 阿柏西普被广泛认为是治疗新生血管性视网膜疾病的关键药物。年龄相关性黄斑变性（AMD）、视网膜静脉阻塞和糖尿病性黄斑水肿等疾病是全球视力损害的主要原因之一，受影响的患者数量持续增长。Neovascular age-related macular degeneration (nAMD), a form of AMD, leads to vision loss in the central field of vision and is a major cause of severe visual impairment in people over 65. Although nAMD accounts for a smaller proportion of total AMD cases, it is responsible for the vast majority of serious vision loss linked to the disease. 新生血管性年龄相关性黄斑变性（nAMD）是年龄相关性黄斑变性的一种形式，会导致中央视野的视力丧失，是65岁以上人群严重视力障碍的主要原因之一。尽管nAMD在所有AMD病例中占比相对较小，但它却是与该疾病相关的绝大多数严重视力损失的罪魁祸首。Across major markets including France, Germany, Italy, Spain, the UK, the US and Japan, an estimated four million people are affected by nAMD. Of these, 2.8 million have been diagnosed, but only about two million receive treatment.. 在包括法国、德国、意大利、西班牙、英国、美国和日本在内的主要市场，大约有四百万人受到nAMD的影响。其中，280万人已被诊断出患病，但只有约两百万人接受治疗。Afqlir® will be introduced gradually across Europe, starting with the UK, followed by Germany and France, with wider availability expected in 2026. Afqlir®将逐步在欧洲推出，首先在英国上市，随后是德国和法国，预计到2026年会有更广泛的供应。The launch strengthens the Sandoz biosimilar portfolio and forms part of the company’s broader growth strategy. It follows recent introductions of biosimilars such as Tyruko® (natalizumab), Wyost® (denosumab) and Jubbonti® (denosumab) in the United States. 此次上市增强了山德士的生物类似药产品组合，并成为该公司更广泛增长战略的一部分。此前，山德士近期在美国推出了诸如Tyruko®（那他珠单抗）、Wyost®（地诺单抗）和Jubbonti®（地诺单抗）等生物类似药。Sandoz aims to support access to essential biologic treatments through a broad and expanding biosimilar portfolio. The company currently offers 13 biosimilars worldwide, with an additional 27 in development. Afqlir® also reinforces the company’s long-standing leadership in biosimilars and enhances its position in the global anti-VEGF ophthalmology market, valued at around USD 15 billion.. 山德士旨在通过广泛且不断扩展的生物类似药组合来支持获取基本的生物疗法。该公司目前在全球提供13种生物类似药，并有另外27种正在开发中。Afqlir®也加强了该公司在生物类似药领域的长期领导地位，并增强其在全球价值约150亿美元的抗VEGF眼科市场中的地位。In September 2025, Sandoz reached an agreement with Regeneron Pharmaceuticals, Inc. to resolve all patent-related disputes concerning its FDA-approved aflibercept biosimilar. This agreement clears the way for the planned US launch of Enzeevu™ (aflibercept-abzv) by the end of 2026. 2025年9月，山德士与再生元制药公司达成协议，解决了与其FDA批准的阿柏西普生物类似药相关的所有专利纠纷。该协议为计划于2026年底在美国推出Enzeevu™（阿柏西普-abzv）扫清了障碍。Source:sandoz.com 来源：sandoz.com

2025-11-19

·药出海

最新：美国FDA已批准的生物类似药汇总

11月13日，美国FDA批准复宏汉霖的Poherdy（pertuzumab-dpzb）生物制品许可申请（BLA），并可与原研Perjeta（帕妥珠单抗）互换使用。Poherdy成为美国首款且唯一的Perjeta生物类似药，覆盖Perjeta在美国已获批的所有适应症，用于 HER2 阳性早期乳腺癌的新辅助/ 辅助和转移性乳腺癌治疗。据了解，帕妥珠单抗原研药于2012年6月获FDA批准上市，2024年的全球销售额约为40.279亿美元。 2025年1-11月美国FDA共批准15种生物类似药 2025年1月至11月期间，FDA批准了15个生物类似药，包括：7种地舒单抗Osvyrti and Jubereq (denosumab-desu)、Enoby and Xtrenbo (denosumab-qbde)、Aukelso and Bosaya (denosumab-kyqq)、Bildyos and Bilprevda (denosumab-nxxp)、Bomyntra and Conexxence (denosumab-bnht)、Stoboclo and Osenvelt (denosumab-bmwo)和Ospomyv and Xbryk (denosumab-dssb)；2种门冬胰岛素Kirsty (insulin aspart-xjhz)和Merilog (insulin aspart-szjj)；帕妥珠单抗Poherdy (pertuzumab-dpzb)；阿柏西普Eydenzelt (aflibercept-boav)；乌司奴单抗Starjemza (ustekinumab-hmny)；贝伐珠单抗Jobevne (bevacizumab-nwgd) ；奥马珠单抗Omlyclo (omalizumab-igec)；托珠单抗Avtozma (tocilizumab-anoh)。盘点：美国FDA已批准的生物类似药截止2025年11月19日，美国FDA共批准78个生物类似药，涵盖20种生物药，包括多款重磅药物，如2024年销售额达103.61亿美元的乌司奴单抗(ustekinumab)、96.45亿美元的阿柏西普(aflibercept)、89.93亿美元的阿达木单抗(adalimumab)等。靶点包括TNF-α、RANKL、IL-12/IL-23、VEGF-A、HER2、TNF-α、IL-6RA、CD20、C5、CD49d、IgE等。其中，FDA于2015年3月批准首个生物类似药 Zarxio（filgrastim-sndz），该药由 Sandoz 公司生产，是 Neupogen（filgrastim）的生物类似药。按照生物类似药获批数量排序，阿达木单抗以10个生物类似药数量稳居第一，其次是地舒单抗和乌司奴单抗各8个。紧跟其后是贝伐珠单抗、阿柏西普、曲妥珠单抗、培非格司亭各6个。根据IQVIA报告，2025至2034年间，将有118种价值2340亿美元的生物药专利到期，但其中仅有约10%的产品有生物类似药在研，27%的高价值生物制品（年销售额>5亿美元）缺乏生物类似药开发，106种产品可能面临无竞争的局面。生物类似药的市场前景如何，欢迎留言交流。参考资料：1、https://www.fda.gov/drugs/biosimilars/biosimilar-product-information2、IQVIA：Assessing the Biosimilar Void in the U.S.3、各公司财报免责声明本公众号所发布的文章，旨在为读者提供一般性的知识、观点和信息。尽管我们努力确保文章内容的准确性与可靠性，但由于知识的不断更新以及实际情况的复杂性，文章内容可能存在一定的时效性与局限性，并不构成专业建议。公众号文章中的观点与评论仅代表作者个人立场，并不一定反映药出海运营主体的观点。我们尊重不同的观点与意见，欢迎读者理性探讨，但对于因文章观点引发的任何争议，本公众号不承担法律责任。 (引用和参考资料如有侵权请及时联系，我们将在24小时内删除处理。) 药品出海合作：Lim 17302664199 器械出海合作：李经理 18682296225 研发合作：郭博士 19166367809 投稿/转载/媒体合作： Zane 15118150289

生物类似药上市批准专利到期财报

2025-10-29

·药学进展

行业动态 | 康哲药业签订眼科药物诺适得®与倍优适®经销协议

“ 点击蓝字关注我们康哲药业签订眼科药物诺适得®与倍优适®经销协议PPS 雷珠单抗注射液（“诺适得®”）是中国首个获批用于眼科的抗VEGF药物，亦是目前中国覆盖年龄段最广泛、适应症最多的抗VEGF药物[1]，超过200项临床研究验证其疗效和安全性。布西珠单抗注射液（“倍优适®”）是目前分子量最小的抗VEGF药物（仅26kDa），产品已获批用于DME并获得权威指南一线推荐[2]。倍优适®的全球3期KESTREL和KITE研究均达到主要疗效终点且视力获益持续至100周，同时在积液消除方面表现更优。倍优适®首年中位注射次数（7次）少于阿柏西普（9次），同时总体安全性与后者相当。两款合作产品均已在中国获批上市，将与康哲维盛在售产品在客户、专家资源、渠道网络上产生高度协同，提升团队整体效能，并为持续合作、开发临床急需的眼科创新产品带来正向推动作用。康哲药业控股有限公司欣然宣布，于2025年10月27日，康哲药业通过子公司CMS VISION INTERNATIONAL MANAGEMENT LIMITED与Novartis Pharma Services AG （“诺华”）就雷珠单抗注射液（“诺适得®”）、布西珠单抗注射液（“倍优适®”）签订经销协议（“协议”）。根据协议，康哲药业获得产品在中华人民共和国的协议所约定之独家进口、经销、销售、推广权利；诺华继续负责生产、供应产品。合作期限为协议约定的生效日起五年。两款合作产品均已在中国获批上市，其中诺适得®是中国首个获批用于眼科的抗血管内皮生长因子（VEGF）药物，具备成熟的临床应用经验，为众多眼底疾病患者提供了可靠保障；诺适得®已被批准用于治疗湿性年龄相关性黄斑变性（nAMD）、糖尿病性黄斑水肿(DME)、视网膜静脉阻塞(RVO)继发的黄斑水肿等多项眼底新生血管性疾病。另一款产品倍优适®为新一代抗VEGF药物，2025年5月中国获批用于DME，其凭借独特的超小分子（仅26kDa）、高浓度创新优势，显著改善视网膜解剖学结构，助力更多DME患者获得视力改善，减轻治疗负担。康哲药业眼科业务公司“康哲维盛”专注于在全球范围内布局、开发临床急需的眼科药械创新产品，致力于打造“中国眼科医药龙头”，此次合作将提升康哲维盛在眼科领域的整体竞争力。康哲维盛已覆盖眼底疾病、视疲劳、青光眼等眼科疾病领域，诺适得®及倍优适®加入后，将与在售独家药施图伦滴眼液（七叶洋地黄双苷滴眼液）、在售独家医疗器械EyeOP1青光眼治疗仪在客户、专家资源、渠道网络上产生高度协同，提升康哲维盛在眼科领域的学术品牌竞争力，为持续合作、开发临床急需的眼科创新产品带来正向推动作用，为眼科疾病患者提供更多元化的治疗选择。同时康哲维盛专业的眼科团队将整合市场渠道与学术资源，提升团队整体效能，并预期对康哲药业业绩产生积极正面影响。关于诺适得®及眼底新生血管性疾病的更多信息诺适得®是重组抗VEGF人源化单克隆抗体Fab片段，靶向抑制人血管内皮生长因子A（VEGF-A），以抑制血管内皮细胞增殖、新生血管生成和血管渗漏。诺适得®作为中国首个获批用于眼科的抗VEGF药物[3]，自2011年在中国上市以来，已被批准用于治疗多项眼底新生血管性疾病，包括nAMD、DME、RVO继发的黄斑水肿、脉络膜新生血管(CNV)、糖尿病视网膜病变（DR）、早产儿视网膜病变(ROP)。诺适得®已于2017年被纳入《国家基本医疗保险、工伤保险和生育保险药品目录》，具备成熟的临床应用经验，为众多眼底疾病患者提供了可靠保障。眼底新生血管性疾病是一类以血管通透性增加、血管渗漏以及血管完整性的缺失为特征的严重致盲性眼病，主要包括nAMD、DR、DME、RVO、CNV、ROP等。抗VEGF药物是多个权威指南推荐治疗眼底新生血管性疾病的一线疗法[3, 4]。根据弗若斯特沙利文报告，中国眼底新生血管性疾病患者预计将从2019年的47.8百万人增至2030年的61.2百万人。中国抗VEGF眼科药物市场预期将从2019年的24亿元增长至2030年的186亿元。根据《抗VEGF药物治疗眼底新生血管性疾病》，诺适得®作为中国首个获批用于治疗眼底新生血管性疾病的抗VEGF药物，在多项临床试验中均显示出良好的安全性和有效性，已被广泛应用于治疗眼底新生血管性疾病，它的问世代表了眼科临床治疗的一个重大进步[5]。关于倍优适®及DME适应证的更多信息倍优适®是一种靶向VEGF-A的新型人源化单链抗体片段，已于2025年5月获得中国国家药品监督管理局批准用于DME。作为目前分子量最小的抗VEGF药物（仅26kDa），倍优适®治疗DME负荷期每6周给药一次（其他抗VEGF药物负荷期每4周给药1次），维持期每2至3个月给药一次。倍优适®针对初治DME患者的全球3期KESTREL和KITE研究均达到主要疗效终点且视力获益持续至100周。倍优适®6mg组患者IRF（视网膜内积液）和/或SRF（视网膜下积液）更少。倍优适®首年中位注射次数（7次）少于阿柏西普（9次），同时总体安全性与后者相当[6]。中国真实世界研究BEST研究显示，经治不达标的DME患者经倍优适®首针治疗1周后BCVA即较基线提升6.1字母，注射第3针（12周）提升10字母，倍优适®为经治DME提供更优化的治疗选择[7]。 DME是由于黄斑区毛细血管渗漏所致的视网膜增厚，是血视网膜屏障破坏的结果，主要影响中心视力[8]。据弗若斯特沙利文报告，2025年中国约有7.89百万例DME患者。但即使按目前规范的抗VEGF药物治疗方案，仍有约30%-50%DME患者积液控制不佳[9–11]。《2022中国常见眼底病慢病管理现状白皮书》调研显示，我国患者治疗依从性较差，30%以上DME患者未能完成负荷期治疗。临床亟需更强效、更持久、依从性更高的治疗药物以改善DME患者的诊疗现状。新一代抗VEGF药物倍优适®为解决这一难题提供了潜在方法，其凭借独特的超小分子、高浓度创新优势，显著改善视网膜解剖学结构，助力更多DME患者获得视力改善，减轻治疗负担。关于诺华诺华是一家全球知名的医药企业，总部位于瑞士巴塞尔。诺华聚焦患者需求紧迫的四大核心治疗领域（心血管、肾脏及代谢，肿瘤，免疫，神经科学）以及五大关键技术平台（化学疗法、生物疗法、xRNA疗法、放射配体疗法、基因和细胞疗法）。参考文献/资料 1.产品相关信息可在诺华官网查询，网址：https://www.novartis.com.cn/news/big-news-noxtex-welcomes-the-approval-of-dual-indications 2.Lim, Jennifer I et al. “Diabetic Retinopathy Preferred Practice Pattern®.”Ophthalmology vol. 132,4 (2025): P75-P162. doi:10.1016/j.ophtha.2024.12.020 3.中华医学会眼科学分会眼底病学组,中国医师协会眼科医师分会眼底病学组.中国年龄相关性黄斑变性临床诊疗指南(2023年)[J].中华眼科杂志,2023,59(5):347-366. 4.许迅,王建影.疾病谱变化驱动临床药物更迭[N].健康报,2023-07-05(005). 5.侯慧敏,常雪柯,靳雨佳,等.抗VEGF药物治疗眼底新生血管性疾病[J].国际眼科纵览,2024,48(6):464-470. 6.Wykoff CC, Garweg JG, Regillo C, et al. KESTREL and KITE Phase 3 Studies: 100-Week Results With Brolucizumab in Patients With Diaßbetic Macular Edema. Am J Ophthalmol. 2024;260:70-83. 7.余洪华，2025中国眼底病论坛暨国际视网膜研讨会，6月4日-7日，中国无锡 8.中华医学会眼科学分会眼底病学组,中国医师协会眼科医师分会眼底病学组. 我国糖尿病视网膜病变临床诊疗指南(2022年)[J]. 中华眼底病杂志,2023,39(2):99-124. 9.戴虹, 卢颖毅. 糖尿病黄斑水肿治疗策略的变化与面临的问题[J].中华眼底病杂志, 2022, 38(1): 6-9. 10.Bressler, Neil M et al.“Persistent Macular Thickening Following Intravitreous Aflibercept, Bevacizumab, or Ranibizumab for Central-Involved Diabetic Macular Edema With Vision Impairment: A Secondary Analysis of a Randomized Clinical Trial.” JAMA ophthalmology vol. 136,3 (2018): 257-269. 11.Chatziralli, I et al. “Identification of time point to best define ‘sub-optimal response’ following intravitreal ranibizumab therapy for diabetic macular edema based on real-life data.”Eye (London, England) vol. 31,11 (2017): 1594-1599. 文章来源：康哲药业美编排版：朱玲欣文章审核：杜雪丽朱玲欣罗琪【免责声明】以上内容来源于互联网，不代表本平台立场或观点；如有侵犯作者著作权，请及时与我们联系（Tel：025-83271227，或直接在微信平台留言），我们将及时更正或删除。《药学进展》杂志由教育部主管、中国药科大学主办，中国科技核心期刊（中国科技论文统计源期刊）。刊物以反映药学科研领域的新方法、新成果、新进展、新趋势为宗旨，以综述、评述、行业发展报告为特色，以药学学科进展、技术进展、新药研发各环节技术信息为重点，是一本专注于医药科技前沿与产业动态的专业媒体。《药学进展》注重内容策划、加强组稿约稿、深度挖掘、分析药学信息资源、在药学学科进展、科研思路方法、靶点机制探讨、新药研发报告、临床用药分析、国际医药前沿等方面初具特色；特别是医药信息内容以科学前沿与国家战略需求相合，更加突出前瞻性、权威性、时效性、新颖性、系统性、实战性。根据最新统计数据，刊物篇均下载率连续三年蝉联我国医药期刊榜首，复合影响因子1.216，具有较高的影响力。《药学进展》编委会由国家重大专项化学药总师陈凯先院士担任主编，编委由新药研发技术链政府监管部门、高校科研院所、制药企业、临床医院、CRO、金融资本及知识产权相关机构近两百位极具影响力的专家组成。联系《药学进展》↓↓↓ 编辑部官网：pps.cpu.edu.cn；邮箱：yxjz@163.com；电话：025-83271227。欢迎投稿、订阅！往期推荐聚焦“第七届药学前沿学术论坛暨《药学进展》编委会会议” 聚力前沿赛道，共启学术新程：第七届药学前沿学术论坛在南京隆重启幕承学术匠心，启时代新章：《药学进展》第七届编委会、第三届青年编委会成立大会在宁召开聚焦“兴药为民·2023生物医药创新融合发展大会”“兴药为民·2023生物医药创新融合发展大会”盛大启幕！院士专家齐聚杭城，绘就生物医药前沿赛道新蓝图“兴药强刊”青年学者论坛暨《药学进展》第二届青年编委会议成功召开“兴药为民·2023生物医药创新融合发展大会”路演专场圆满收官！校企合作新旅程已启航我知道你在看哟

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100 项与阿柏西普生物类似药 (Sandoz ) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XX44 S01LA05	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
黄斑变性	加拿大	山德士有限公司	2025-10-01
视力低下	澳大利亚	Sandoz Pty Ltd.	2025-05-27
糖尿病性黄斑水肿	欧盟	Sandoz GmbH	2024-11-13
糖尿病性黄斑水肿	冰岛	Sandoz GmbH	2024-11-13
糖尿病性黄斑水肿	列支敦士登	Sandoz GmbH	2024-11-13
糖尿病性黄斑水肿	挪威	Sandoz GmbH	2024-11-13
近视脉络膜新生血管	欧盟	Sandoz GmbH	2024-11-13
近视脉络膜新生血管	冰岛	Sandoz GmbH	2024-11-13
近视脉络膜新生血管	列支敦士登	Sandoz GmbH	2024-11-13
近视脉络膜新生血管	挪威	Sandoz GmbH	2024-11-13
视网膜静脉阻塞相关黄斑水肿	欧盟	Sandoz GmbH	2024-11-13
视网膜静脉阻塞相关黄斑水肿	冰岛	Sandoz GmbH	2024-11-13
视网膜静脉阻塞相关黄斑水肿	列支敦士登	Sandoz GmbH	2024-11-13
视网膜静脉阻塞相关黄斑水肿	挪威	Sandoz GmbH	2024-11-13
湿性年龄相关性黄斑变性	美国	Sandoz, Inc.	2024-08-09

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临床结果

适应症

分期

评价

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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


NCT04864834 (Mylight, Corporate Publications) 人工标引	临床3期	湿性年龄相关性黄斑变性	485	aflibercept	齋糧膚鏇製製顧餘鬱獵(夢齋淵鬱膚憲選顧憲顧) = The Mylight Phase III confirmatory efficacy and safety study met its primary efficacy endpoint, showing therapeutic equivalence in mean change of best corrected visual acuity (BCVA) from baseline to week 8 between the biosimilar aflibercept and the reference biologic, Eylea®. 窪糧範蓋鏇選蓋鹽壓鹹 (餘鹹簾壓範廠範餘淵夢 ) 达到	积极	2023-08-15
				Eylea
NCT05282004 (CTgov)	临床3期	湿性年龄相关性黄斑变性	36	SOK583A1	構網獵憲鹽衊襯獵蓋顧 = 簾鏇壓餘廠醖淵觸觸繭製鹽獵簾願夢網獵選窪 (鬱夢醖憲構築窪遞廠鬱, 鹽顧構觸網襯顧膚鏇製 ~ 簾憲糧鬱鏇願築觸糧簾) 更多	-	2023-05-10
NCT05161806 (CTgov)	临床3期	湿性年龄相关性黄斑变性	30	Prefilled Syringe (PFS)+SOK583A1 (40 mg/mL)	鬱餘遞觸獵鹽衊構窪範 = 憲鹽蓋憲憲遞願餘淵範鏇襯顧獵觸鬱糧觸鹹繭 (蓋衊構築築網襯憲鏇鏇, 遞醖選窪顧構糧選積範 ~ 膚築憲蓋艱憲築鹹觸鹹) 更多	-	2022-11-18
EURETINA2021	N/A	-	-	Aflibercept	鑰鬱遞觸淵築襯糧選構(選製製鏇網遞顧鹽淵範) = 鑰艱衊獵壓醖蓋夢鏇顧願夢選淵襯範繭餘窪願 (鏇鏇獵艱淵獵鏇鹽願夢, 12.5) 更多	-	2021-09-01
				Ranibizumab-PFS	餘餘獵襯衊蓋範構構觸(糧鬱廠齋鹹廠積齋壓範) = 艱衊鏇繭願蓋齋積選淵範壓膚壓齋齋積憲膚願 (鏇簾餘衊範築鏇鬱憲淵 )
PROOF study (EURETINA2021)	N/A	湿性年龄相关性黄斑变性 anti-VEGF	600	Ranibizumab	壓醖夢窪簾鑰鑰壓範範(蓋襯鹽膚鏇壓鑰鹽選壓) = 構觸顧製積艱製餘壓壓構齋糧觸願鹽鹽獵廠觸 (鏇顧壓網鏇醖獵廠淵顧, 20.69) 更多	积极	2021-09-01
				Aflibercept	壓醖夢窪簾鑰鑰壓範範(蓋襯鹽膚鏇壓鑰鹽選壓) = 鹹襯衊簾獵淵構衊獵網構齋糧觸願鹽鹽獵廠觸 (鏇顧壓網鏇醖獵廠淵顧, 20.69) 更多
OSPREY (ARVO2021)	临床2期	湿性年龄相关性黄斑变性	81	Brolucizumab	餘製鹽選窪醖簾築鬱糧(襯餘憲構膚壓鏇糧選顧) = 廠鹽夢鹽餘襯網糧繭繭鹽鹽醖積簾構襯積膚淵 (獵鹹顧鏇鹽構獵網齋艱 ) 更多	-	2021-06-01
				Aflibercept	觸鹹襯範簾顧廠選願醖(鹽鹹網衊糧選遞築網構) = 窪獵鏇糧蓋襯艱繭壓蓋夢衊餘衊構積範鏇醖顧 (簾齋願鬱構構網願構憲 ) 更多
OSPREY (ARVO2020)	临床2期	湿性年龄相关性黄斑变性	-	Brolucizumab 6 mg	簾鑰顧選獵糧鹽窪鏇顧(簾獵憲選鏇壓選鹽製繭) = 鬱網網簾廠繭築願蓋範構艱願願襯網糧鹽構鹹 (觸衊襯鏇壓糧鹹選艱艱 ) 更多	积极	2020-06-01
				Aflibercept 2 mg	簾鑰顧選獵糧鹽窪鏇顧(簾獵憲選鏇壓選鹽製繭) = 構壓襯夢觸醖鹽鬱鹽簾構艱願願襯網糧鹽構鹹 (觸衊襯鏇壓糧鹹選艱艱 ) 更多
ARVO2016	N/A	湿性年龄相关性黄斑变性	110	Ranibizumab	積壓鹹積鏇廠衊蓋淵醖(襯憲鏇網繭醖選簾顧遞) = 膚構積鏇襯齋鬱鹹鏇襯艱築糧衊範壓鏇鹹繭淵 (蓋衊鏇構鑰淵醖鹹簾獵, 258.63 ~ 284.95) 更多	积极	2016-05-01
				Aflibercept	積壓鹹積鏇廠衊蓋淵醖(襯憲鏇網繭醖選簾顧遞) = 淵鑰蓋廠蓋遞鹹壓衊廠艱築糧衊範壓鏇鹹繭淵 (蓋衊鏇構鑰淵醖鹹簾獵, 235.03 ~ 257.62) 更多