A Multi Center, Extension Study to Evaluate the Safety and Efficacy of MYL-1701P in Subjects With Diabetic Macular Edema Completed MYL-1701P-3001 Study.

This Study (AFIL-IJZ-3002) is designed to evaluate the safety, efficacy and immunogenicity of MYL-1701P among a group of participants successfully completing MYL-1701P-3001 study.

开始日期2020-11-23

申办/合作机构

Mylan Pharmaceuticals, Inc.

[+1]

CTRI/2020/11/028961

/ Completed临床3期

A Multi center, Extension Study to Evaluate the Safety and Efficacy of MYL-1701P in Subjects with Diabetic Macular Edema Completed MYL-1701P-3001 Study.

开始日期2020-11-03

申办/合作机构

Mylan, Inc.

[+1]

EUCTR2017-004358-40-DE

/ Not yet recruiting临床3期

A Multi Center, Randomized, Double-Masked, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects with Diabetic Macular Edema

开始日期2018-12-04

申办/合作机构

Mylan, Inc.

100 项与阿柏西普生物类似药(Viatris) 相关的临床结果

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项与阿柏西普生物类似药(Viatris) 相关的文献（医药）

2024-10-01·JAMA Ophthalmology

Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema

Article

作者: Agrawal, Virendra ; Zeitz, Oliver ; Ganapathi, Prasanna C. ; Varsanyi, Balazs ; Oh, Hideyasu ; Stoller, Glenn L ; Furuta, Minoru ; Brown, David M ; Ghorayeb, Ghassan R ; Mazumdar, Shahana ; Zalewski, Dominik ; Barakat, Mark R ; Chang, Margaret A ; Korda, Vladimir ; Ojima, Akira ; Kalvodova, Bohdana ; Chaudhry, Nauman A ; Apte, Rajendra S. ; Vajas, Attila ; Chauhan, Rohan R ; Barve, Abhijit ; Kobayashi, Namie ; Kitaoka, Takashi ; Mansour, Sam E ; Laganovska, Guna ; Muramatsu, Tomoyuki ; Grisanti, Salvatore ; K, Minija C ; Studnicka, Jan ; Dessouki, Amr L ; Agarwal, Somesh ; Gombos, Katalin ; Zolotarev, Andrey ; Kellner, Ulrich ; Behera, Umesh Chandra ; Alfaro, Daniel Virgil ; Nemcansky, Jan ; PD, Katrin Lorenz ; Agarwal, Komal ; Reichstein, David A. ; Radnoti, Judit ; Natesh, Sribhargava ; Veith, Miroslav ; Narayanan, Raja ; Thach, Allen B ; Rehak, Jiri ; Dégi, Rozsa ; Kaza, Hrishikesh ; Tabassian, Ali R ; Kannan, Naresh Babu ; Rahul, Shroff ; Yadav, Naresh Kumar ; Noge, Sumiyo ; Fox, Gregory M ; Davies, John B ; Fujita, Hideaki ; Shkvorchenko, Dmitry ; Fluder, Ewa Maria ; Astakhov, Yury ; Tanabe, Teruyo ; Astakhov, Sergei ; Kerenyi, Agnes ; Krzyzanek, Daniel ; Elhence, Arti ; Tsorbatzoglou, Alexis ; Loganathan, Subramanian ; Panchal, Bhavik ; Yoshizumi, Yuki ; Ebihara, Nobuyuki ; Baumane, Kristine ; Kamei, Motohiro ; Beckmann, Katrin ; Doi, Norihito ; Imaizumi, Hiroko ; Patel, Sunil S. ; Gamulescu, Maria- Andreea ; Izmaylov, Alekxandr ; Borcz, Emilia ; Gupta, Vishali ; Sekundo, Walter ; Eremina, Alena ; Oshima, Yuji ; Seres, Andras ; Ernest, Jan ; Wylegala, Edward ; Raj, Lional ; Marcus, Dennis M. ; Ozolina, Signe ; Samoylov, Alexandr ; Patel, Sunil S ; Otake, Hiroshi ; Nawrocki, Jerzy ; Kiss, Katalin K ; Bressler, Susan B. ; Eichenbaum, David A ; Oleksy, Piotr ; Watanabe, Miki ; Johnson, Thomas Mark ; Berger, Adam S ; Stodulka, Pavel ; Kawasaki, Tsutomu ; Degi, Rozsa ; Saito, Isao ; Hanemoto, Tsukasa ; Lebedev, Oleg ; Fine, Howard F ; Gordon, Alan J ; Angle, Bryan N ; Feltgen, Nicolas ; Reichstein, David A ; Sonawane, Ashwini ; Kaga, Tatsushi ; Saravanan, Veerappan R ; Murata, Koji ; Abe,, Keitetsu ; Sawada, Osamu ; Budzinskaya, Maria ; Aggarwal, Somesh ; Dugel,, Pravin U ; Dahlke, Claudia ; Ishii, Kiyoshi ; Marcus, Dennis M ; Matsuda, Satoshi ; Baker, Carl W ; Sjaarda, Raymond N ; Kishino, Genichiro ; Vohra, Rajpal

ImportanceBiosimilars may be lower-cost alternatives to originator biologic products, potentially offering expanded access or reduced economic burden, but have not been evaluated with aflibercept in diabetic macular edema (DME).ObjectiveTo compare efficacy and safety of MYL-1701P, an aflibercept biosimilar, with reference aflibercept (Eylea [Regeneron]) in DME.Design, Setting, and ParticipantsThis was a double-masked, randomized clinical trial that included participants at 77 centers across the US, Europe, Japan, and India. Included in the analysis were individuals 18 years and older with type 1 or type 2 diabetes with central DME and best-corrected visual acuity (BCVA) letter score of 73 to 38 in the study eye using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Study data were analyzed from October to December 2021.InterventionsFormulations of MYL-1701P (0.5-mg vial) or reference aflibercept every 4 weeks for 5 consecutive intravitreal injections, followed by every 8 weeks through week 52.Main Outcomes and MeasuresThe primary outcome was the adjusted difference in least squares mean (SE) change from baseline BCVA letter score at week 8 with an equivalence margin of −3 to +3 letters. Secondary outcomes included change in central subfield thickness (CST), BCVA, number of injections over 52 weeks, incidence of adverse events (AEs), and antidrug antibodies (ADAs).ResultsA total of 355 participants (mean [SD] age, 62.2 [9.2] years; 216 male [60.8%]) were randomized to MYL-1701P (179 participants [50.4%]) and aflibercept (176 participants [49.6%]). At week 8, mean (SE) change in BCVA was 6.60 (0.55) letters vs 6.56 (0.55) letters in the MYL-1701P vs aflibercept groups. The adjusted mean difference of 0.04 letters (90% CI, −1.16 to 1.24 letters) met the primary outcome. At week 8, mean (SE) change in CST was −112 (7) μm vs −124 (7) μm in the MYL-1701P vs aflibercept groups (adjusted mean difference, 12 μm; 90% CI, −3 to 26 μm). The incidence of treatment-emergent AEs in the MYL-1701P and aflibercept arms were ocular (30.9% [55 of 178] vs 29.5% [52 of 176]), serious ocular (0.6% [1 of 178] vs 1.1% [2 of 176]), nonocular (65.2% [116 of 178] vs 65.3% [115 of 176]), and serious nonocular (16.9% [30 of 178] vs 11.9% [21 of 176]). The mean (SD) total number of injections was 8.4 (2.1) vs 8.7 (1.8) in the MYL-1701P vs aflibercept groups. The incidence of treatment-induced or treatment-boosted ADAs was 2.8% (5 of 177) vs 5.7% (10 of 176) in the MYL-1701P vs aflibercept arms.Conclusions and RelevanceMYL-1701P demonstrated clinical equivalence in regard to efficacy, with comparable safety and immunogenicity, to reference aflibercept. These findings support use of MLY-1701P as an alternative to reference aflibercept.Trial RegistrationClinicalTrials.gov Identifier: NCT03610646

1989-02-01·Scandinavian Journal of Immunology4区 · 医学

Reduced Erythrocyte CR1 (CD 35) Receptor Function and Complement Opsonization in Factor I‐Deficient Patients is Restored by Plasma Infusion

4区 · 医学

Article

作者: S E Svehag ; H H Jepsen ; B Teisner ; J M Rasmussen

Erythrocytes (E) from three factor I‐deficient patients were investigated for surface‐bound complement factors and CR1 (CD 35) expression and function. The E were coated with C4b,C3b, and factor H. Following plasma infusion of in vitro incubation of the patients’ E with normal human serum (NHS) or purified factor I, cell‐bound C4b and C3b could no longer be detected. The E now expressed C3d, and factor H was unaffected, indicating that factor H was hound to the C3d part of the C3b molecules, providing the co‐factor for effective cleavage of E‐bound C3b when purified factor 1 was added. The binding of monoclonal anti‐CR1 antibodies (M710) to the patients’ E was markedly reduced compared with control E, and was not normalized by treatment with NHS, probably because covalently bound C3d/factor H interfered with the binding of M710. By contrast, the reduced ability of the patients’ E‐CR1 to bind complement‐opsonized immune complexes (IC) was normalized after plasma infusion. This shows that the impaired CR1 function was acquired and emphasizes the importance of performing functional CR1 assays. Complement opsonization of IC for binding to normal E was severely compromised in the patients’ sera due to consumption of factor B and C3. After plasma infusion the opsonization capacity of the patients’ sera was restored. Thus, two mechanisms of importance for normal clearance of IC were compromised in factor I‐deficient patients: (1) the opsonization of IC for binding to E‐CRI, and (2) the capacity of E‐CRI to bind opsonized complexes. Both dysfunctions were temporarily corrected by plasma infusion.

1986-01-01·Immunopharmacology and Immunotoxicology

Complement Receptors (CR) and Cytotoxic Responses: Monoclonal Antibodies Directed Against CR1 AMD CR3 Inhibit the Generation of Human Allospecific and Virus Specific Cytotoxic Cells in Vitro

Article

作者: John D. Lambris ; George C. Tsokos ; Giorgio Inghirami

A variety of cellular immune responses involve complement factors which bind to specific receptors, and modulate or effect a specific reaction. Monoclonal antibodies (MAb) have been generated against complement receptors (CR) 1 and 3, which were utilized to investigate human allogeneic and Epstein-Barr virus specific cytotoxic cells in vitro. MAb OKM1, which binds to the C3bi CR (CR3), and MAb M710, which binds to the C3b/4b CR (CR1), inhibited the generation of both allogeneic and virus specific cytotoxic responses in vitro in a dose-dependent way; doses of 1 microgram/ml (or greater) completely abrogated the cytotoxic responses. Inhibition of these responses was observed when the MAb was added to the cultures at any time point except the last two days. In addition, treatment of the responder (but not the stimulator cells) with either MAb resulted in complete inhibition of cytotoxic responses. These experiment indicate that complement receptors participate in the generation of human cytotoxic responses in vitro.

项与阿柏西普生物类似药(Viatris) 相关的新闻（医药）

2024-10-29

·同写意

围攻眼科药王

此次医博会由同写意策划，以“发展新质生产力，共享健康新未来”为主题，用全新的视角瞄准国内外医药及大健康产业发展前沿。诚邀海内外医药及大健康各界嘉宾齐聚中国医药城，共赴时代之约。展位/报告火热征集中！近期，罗氏眼科双抗法瑞西单抗（Vabysmo）新适应症在华获批，用于治疗视网膜静脉阻塞继发黄斑水肿（MEfRVO）。眼科药王阿柏西普（Eylea）再受打击。自2015年销售额反超雷珠单抗（Lucentis）以来，阿柏西普一直统治着整个眼科抗VEGF药物市场，且常年霸榜全球畅销药物TOP10。但随着专利到期，在即将来临的大量生物类似药以及创新药的围剿下，阿柏西普岌岌可危。 1 钻石赛道开启视力障碍是一种改变生活的疾病，影响着全球约22亿人。据沙利文报告，2022年全球眼科药物市场规模已经达到372亿美元，预计2030年将达到734亿美元。2022年中国的规模达到43亿美元，预计2030年将达到169亿美元。图一：眼科药物市场规模来源：参考来源1 眼科药物市场增长迅猛，是非肿瘤领域的钻石赛道。而这一赛道内最亮眼的明星药物类别，自然属于诞生了眼科药王阿柏西普的抗VEGF药物（anti-VEGF，抗血管内皮生长因子）。 VEGF是一种促进血管内皮细胞增生的分子，VEGF家族包括VEGF-A、VEGF-B、VEGF-C、VEGF-D、VEGF-E和胎盘生长因子（PIGF），具有促进血管通透性增加、细胞外基质变性、血管内皮细胞迁移、增殖和血管形成等作用。研究发现VEGF的高表达与年龄相关性黄斑变性（AMD）、糖尿病视网膜疾病变（DR）等视网膜疾病密切有关，因此，VEGF成为了治疗眼科疾病的潜力靶点。历经多年开发，眼科抗VEGF药物目前已成为视网膜疾病的首要疗法，包括湿性年龄相关性黄斑变性（nAMD）、糖尿病性视网膜病变(DR)、糖尿病性黄斑水肿(DME)和视网膜静脉阻塞（RVO）以及早产儿视网膜病变（ROP）。其中，年龄相关性黄斑变性与糖尿病视网膜病变均位居引发视力障碍或失明的前五大原因。年龄相关性黄斑变性（AMD）是一种广泛分布的眼科疾病，主要影响老年人的视力，全球估计有1400万人受到影响。它是60≥岁个体中心视力丧失的主要原因之一。其中，湿性AMD也称为渗出性AMD或新生血管性AMD（nAMD），影响全球超过1500万人，约占70岁及以上人口的5%。而糖尿病视网膜病变（DR）是糖尿病的一种普遍的微血管并发症，影响大约30-40%的糖尿病患者，其中DME是DR的最普遍并发症之一。并且，近年来随着老年化加剧与糖尿病患病率的逐年上升，nAMD与DR、DME患病人数将持续上升。根据弗若斯特沙利文数据，仅中国2022年便分别有400万例nAMD、730万例DME患者，预计到2026年，患者人群数量将扩大至440万例nAMD和790万例DM，市场潜力巨大。随着商业化开发的深入，三种药物接力拉开了钻石赛道的帷幕。眼科抗VEGF药物的历史由哌加他尼（Macugen）在2004年首度开启，但在临床试验中，哌加他尼的临床数据虽优于安慰剂，大多数患者视力仍然呈下降趋势，现在临床已很少应用此药。图片2：眼科抗VEGF药物时间线参考来源：公开资料整理哌加他尼是先行者，但是眼科抗VEGF药物的第一次辉煌却由罗氏2006年上市的雷珠单抗所铸造。相较于哌加他尼的不温不火，雷珠单抗因疗效显著，在上市后很快名声大噪，首年便实现了7.1亿美元的销售额。上市首年《科学》杂志还将其评为年度十大科技成果之一，称其为“人类历史上第一次让AMD患者视力得到提高的疗法”。在2011年前，雷珠单抗可以说是独霸眼科抗VEGF药物市场，其巅峰销售额超过43亿美元。一直到再生元的当家花旦阿柏西普上市，眼科抗VEGF药物先锋雷珠单抗备受打击，进入了屈辱时代。阿柏西普的崛起可谓是抗VEGF眼科药物市场上的一场“突袭”。凭借着其最长可以三个月给药一次的优势，阿柏西普犹如一匹黑马，迅速在湿性老龄相关性黄斑变性（nAMD）治疗领域中站稳脚跟。它的推出不仅改变了治疗方式，还给竞争对手雷珠单抗带来了一场“市场地震”。图片3：阿柏西普与雷珠单抗销售额对比来源：参考来源2 在阿柏西普上市年后的第一年，它便差点突破10亿美元销售额大关，给当时市场占主导地位的雷珠单抗造成了强烈冲击。到2015年，阿柏西普不但成功反超了雷珠单抗，还登上了全球抗VEGF药物销售冠军的宝座，并自此一路高歌猛进，成为这个市场上无可争议的霸主，常年霸榜全球畅销药物TOP10。继眼科药王诞生，眼科药物这一钻石赛道终于真正的被阿柏西普完全开启。 2 前后围剿专利悬崖是重磅药物们避不开的梦魇。前任全球药王修美乐在巅峰时期（如2022年）的销售额达到了212.37亿美元，然而，到了2023年，其销售额骤降至144.04亿美元，同比下滑了32.2%。进入2024年，修美乐的颓势依旧未改，第一季度销售额仅为22.7亿美元，同比下降了35.89%，且全年销售额极大概率难以破百亿美元。罗氏的三驾马车贝伐珠单抗(Avastin)、利妥昔单抗(Rituxan)和曲妥珠单抗(Herceptin)，23年销售额合计不足45亿瑞士法郎，较巅峰时期缩量近80%。虽然从现有竞争格局来看，阿柏西普仍然具有极大的销售优势，但时间却不站在它这边。在生物类似药大举进攻之前，全新作用机制的双抗药物早已经发起奇袭。法瑞西单抗（Vabysmo）是一款双特异性抗体药物，开发用于治疗眼科疾病，特别是与视网膜血管异常相关的疾病。它由罗氏（Roche）旗下的基因泰克（Genentech）开发，主要针对两种靶点：血管内皮生长因子A（VEGF-A）和血管生成素-2（Ang-2）。法瑞西单抗的双重靶点机制使其不仅可以抑制VEGF-A的作用，还能够抑制Ang-2，后者也是血管生成和血管渗漏的关键调节因子。通过这种双重抑制，法瑞西单抗在减少病理性血管生成、改善血液循环和减缓炎症反应方面显示出了较强的潜力。法瑞西单抗已经在多个临床试验中取得了良好效果，并于2022年被美国食品和药物管理局（FDA）批准用于治疗nAMD和DME。与阿柏西普相比，法瑞西单抗将治疗周期延长到了每4个月一次，显著的减小了注射次数。由于优异的药效，法瑞西单抗的销售额一经上市便开始大幅放量（23年已达23.57亿瑞士法郎），并对阿柏西普的销售进行了冲击（阿柏西普2023年的全球销售额为92.15亿美元，同比下滑4%）。除了强力新竞品的冲击，生物类似药们更是已经蓄势待发。从全球市场来看，早在2021年10月，Mylan就向FDA递交了M710的上市申请，2021年12月获得了FDA的受理。随后，Formycon和Celltrion等公司接连向FDA发起了阿柏西普生物仿制药的申请。截至目前，已有五款阿柏西普的生物类似药获得FDA批准，最新批准的为安进在2024年8月获批上市的Pavblu。虽然再生元想法设法的通过专利诉讼进行阻止，如其在2024年1月对安进提起了侵权诉讼，指控Pavblu侵犯了阿柏西普32项专利，请求法院下令禁止安进上市销售Pavblu。但在2024年9月24日，美国西弗吉尼亚州地方法院驳回了“再生元阻止阿柏西普生物类似药Pavblu上市销售”的诉讼请求。裁决结果公布后，再生元股价应声下跌。从国内市场来看，2023年12月,齐鲁制药阿柏西普生物类似药获批上市，成为国产首款，将和12月在中国同时获批的法瑞西单抗共同携手打破国内市场此前雷珠单抗、阿柏西普、康柏西普的三足鼎立之势。此外，2024年7月16日,CDE网站显示,博安生物的阿柏西普眼内注射溶液申报上市。该品种是第2款申报上市的国产阿柏西普生物类似药。生物类似药的大幅入侵已成定局。除开已上市的入局者们，从研发端口来看，全球范围内至少有105个抗VEGF眼科药物项目在研（截至2023年10月）。其中，仅与最炙手可热的法瑞西单抗拥有共同靶点VEGF/ANG-2的双抗药物就已有至少8款在研。图片4：眼科双抗竞争格局来源：参考来源3 国内市场的研发更是如火如荼，目前处于三期临床阶段靶向 VEGF 眼科类似药就有5款，其中阿柏西普、雷珠单抗分别有3款、2款。图片5：国内眼科双抗竞争格局来源：参考来源3 创新药方面，目前国内至少有18款在研眼科抗VEGF创新药。全球市场与国内市场的众多竞争者们都已迫不及待入场分食眼科药王阿柏西普的市场。而在即将到来的创新药与生物类似药的全面围剿下，不知阿柏西普是否在那些前任药王的历史里早已经看到了自己惨痛的未来。 3 继承者们阿柏西普在其原研厂家再生元心里有着极为特殊的情感。作为再生元开发的第一个大药，是它将上市后便陷在财务困境中二十年的再生元拉出泥潭，也是它见证成再生元从一个初创企业成为了营收超百亿美元、市值超千亿美元的制药巨头（Eylea推出后，股价5年间翻了10倍）。图片6：再生元营收来源：参考来源4 尽管不舍，尽管提起了大量专利诉讼，尽管开发了高剂量HD，但也仅仅只能延缓阿柏西普的衰败之路，事物发展的客观大势无法阻挡. 但幸运的是，继承者们已至。就如同打造了前任药王修美乐的艾伯维，修美乐重挫后，其还有瑞莎珠单抗（SKYRIZI）和乌帕替尼（Rinvoq）来接棒。2023年，Skyrizi的销售额为77亿美元，同比增长50%，Rinvoq销售额为39亿美元，同比增长57%。两者销售额共计超过100亿美元，到2027年将超过修美乐达到270亿美元的峰值收入。就如同打造了三架马车的罗氏，老三架马车失速后，新三架马车帕妥珠单抗（Perjeta）、恩美曲妥珠单抗（Kadcyla）、阿替利珠单抗（Tecentriq）也早已扬帆起航，在2021年反超了销售额下滑的老三架马车。再生元也有阿柏西普的继承者，即度普利尤单抗（Dupixent）。作为全球首个获批上市的IL-4Rα靶向单抗，度普利尤单抗市场表现非常亮眼，2023年销售已突破百亿美元(115.89亿美元)，跻身2023全球畅销药TOP6，且在24年上半年销售额已经超越阿达木单抗，荣升全球自免药王。对于再生元来说，度普利尤单抗在阿柏西普失势之后还会陪着他走很远的路，也能够在很长的时间里提供再生元所需的资金与前进动力，再生元可以放手去打造更多的重磅药物。图片7：再生元临床项目来源：参考来源4 截止2024年8月报告，目前再生元拥有包括肿瘤、自免、眼科等重磅领域在内至少35个临床在研药物，其中10个已经进入了临床三期，增长动力十足，相信后续其会持续给到我们惊喜。最后，对于一家药企而言，纪念优秀前任最有力的方式，也许就是开发出一款又一款畅销的重磅药物。参考文献： 1、前浪后浪“争斗”不休，VEGF眼药市场谁主沉浮？，药智头条 2、《中国药品制剂行业发展态势分析与投资战略评估报告（2022-2029年）》，观研天下 3、申万宏源、西南证券研究 4、各公司官网 5、Ophthalmic Use of Targeted Biologics in the Management of Intraocular Diseases: Current and Emerging Therapies. https://doi.org/10.3390/antib13040086 同写意媒体矩阵，欢迎关注↓↓↓

专利到期

2024-10-23

·BioSpace

Roche Beats Q3 Sales Estimates as CEO Voices Opposition to Novo Holdings-Catalent Merger

iStock, Robert Way Jefferies analyst Peter Welford noted that Roche’s pharma group came just slightly ahead of consensus expectations, driven by strong performance of its multiple sclerosis therapy Ocrevus and eye injection Vabysmo. Roche on Wednesday released its third-quarter earnings report , posting nearly $17.5 billion in sales, representing 9% year-on-year growth and exceeding Wall Street expectations. According to Jefferies analyst Peter Welford, Roche’s Q3 sales were 1% ahead of the consensus estimate. The company’s pharmaceuticals division, which remains its strongest unit with $13.4 billion in the quarter, beat analysts’ expectations by 2%. Roche’s top-performing asset in the quarter was the multiple sclerosis drug Ocrevus, which grew 11% to bring in almost $2 billion. Despite mounting biosimilar competition in the eye diseases space, Roche’s intravitreal injection Vabysmo continues its strong market momentum. The age-related macular degeneration (AMD) treatment surged 59% year-over-year, bringing in nearly $1.2 billion in Q3. Vabysmo, a dual inhibitor of VEGF and angiopoietin-2, is also indicated for diabetic macular edema (DME). In May 2024, the FDA greenlit two biosimilars to Regeneron’s blockbuster therapy Eylea—Samsung Bioepis and Biogen’s Opuviz and Biocon Biologics’ Yesafili—which are expected to compete with Vabysmo in the AMD and DME markets. On the negative side of the Q3 ledger, Roche’s PD-L1 antibody Tecentriq was “weak” in the quarter, according to Jefferies’ Welford, noting that its sales of just over $1 billion fell short of consensus estimates. Looking forward to the rest of the year, Roche reiterated its business outlook with growth of around mid-single-digit in group sales and in the high-single-digit range for core earnings-per-share. Opposition to Novo-Catalent Deal On the M&A front, Roche is urging regulatory authorities to block Novo Holdings’ proposed $16.5 billion acquisition of CDMO giant Catalent, arguing that the deal would have wide-ranging negative effects on the industry. “Limiting the competition in this space is not a good idea,” Roche CEO Thomas Schinecker said in a media call Wednesday morning, however insisting that the company itself would not be affected by the merger, according to Reuters . The acquisition would further restrict the contract manufacturing ecosystem, Schinecker said, which “could be a problem for other smaller players.” “From an industry perspective, it would be a wrong decision by authorities” if they let the transaction proceed, according to Schinecker. Pressure on the deal has been mounting. Last week, more than 10 unions, consumer organizations and public interest groups wrote to the Federal Trade Commission , urging the antitrust watchdog to “challenge” the proposed acquisition and to ensure that “competition is protected.” Sen. Elizabeth Warren (D-Mass.) earlier this month also flagged potential anti-competitive concerns with the transaction. In a letter to the FTC, Warren warned that the acquisition of contract manufacturer Catalent could increase Novo Nordisk’s dominance over the hot GLP-1 market, reducing competition and increasing prices. Referring to rival Eli Lilly, Warren said the deal could give Novo Nordisk “unprecedented visibility into and control over its competitor’s production capacity, costs, and business practices,” as well as “the ability to preference its own products and obstruct its competitors’ use of Catalent to produce GLP-1 drugs.” Lilly CEO David Ricks said in a Q2 earnings call in August that the company remains concerned about the Novo-Catalent deal. “We do rely on one of the Catalent sites for GLP-1 and other diabetes production,” Ricks told analysts. “We’ve aired those concerns publicly and privately since the proposed transaction was announced, and we’re waiting to see what happens.”

并购

2024-09-24

·FiercePharma

Regeneron's stock drops as it loses bid to block Amgen's Eylea biosimilar

Regeneron suffered a setback in its defense of blockbuster eye drug Eylea, startling investors. Three months after a federal judge in West Virginia sided with Regeneron, blocking the market entry of two biosimilars for blockbuster eye disease drug Eylea, the same judge has rejected the company’s attempt to block Amgen’s Eylea biosimilar.In an order issued under seal—which would explain his decision—Judge Thomas Kleeh of the U.S. District Court for Northern District of West Virginia denied Regeneron’s request for a preliminary injunction which would prevent Amgen’s Pavblu from entering the market.The knockoff, which replicates the original 2 mg version of Bayer and Regeneron’s Eylea, was approved by the FDA last month. In its complaint against Amgen, which was filed in January of this year, Regeneron listed 32 patents it claimed were infringed. Upon the decision, the company immediately filed an appeal."We are disappointed in the court decision that was specific to Amgen only. Importantly, this decision has no effect on previous decisions against other biosimilars manufacturers of Eylea," Regeneron said in an emailed statement. "We continue to believe that Amgen is infringing our patent rights, and this decision denying our request for a preliminary injunction is not the final word in this litigation. We have appealed this decision, and we also look forward to presenting our case at trial."The New York-based company’s regulatory exclusivity for Eylea—which was originally approved in 2011 to treat wet age-related macular degeneration (AMD)—expired in May, according to the complaint.As Regeneron's case plays out, Amgen could now pursue an "at-risk" biosimilar launch. Under such an approach, the biosimilar maker would be liable for damages should Regeneron ultimately prevail in establishing patent infringement.In the wake of the injunction decision, Regeneron’s shares dropped roughly 9% between Monday and Tuesday, an indicator of the company’s reliance on Eylea.With U.S. sales of $5.9 billion in 2023, the vascular endothelial growth factor (VEGF) inhibitor accounted for 44% of Regeneron revenue of $13.1 billion.An Amgen spokesperson said that the company will "announce our launch timing in due course," Eylea’s market share has been dented by Roche’s longer-acting Vabysmo, which requires dosing as little as every four months as opposed to every other month for Eylea. Regeneron has since countered with a high-dose (8 mg) version of Eylea. In the second quarter, Eylea HD accounted for $304 million of the $1.53 billion generated overall by the Eylea franchise. The Amgen ruling runs counter to Kleeh’s decisions three days apart in June when he granted Regeneron’s requests for preliminary injunctions, blocking the sale of Biogen and Samsung Bioepis’ Eylea biosimilar Opuviz and Biocon’s Eylea copycat Yesafili until 2027. The court ruled that both knockoffs infringed Regeneron patents.Opuviz and Yesafili were approved by the FDA in May as interchangeable biosimilars, meaning that a pharmacist can freely switch them out for the reference product. Regeneron’s defense of Eylea is a high-priority endeavor for the drugmaker. Four weeks ago, the company filed a lawsuit in New Jersey against Sandoz and its Eylea biosimilar. The company also is jousting with South Korea-based Celltrion and Germany-based Formycon over their Eylea biosimilars.Eylea works by inhibiting the growth of abnormal blood vessels in the retina and reducing fluid leakage. This mechanism helps in managing and treating conditions that lead to vision loss. In addition to its AMD nod, Eylea has been endorsed by the FDA to treat diabetic macular edema (DME), retinal vein occlusion (RVO), diabetic retinopathy (DR) and retinopathy of prematurity (ROP).

上市批准专利侵权生物类似药

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批准上市

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适应症	国家/地区	公司	日期
糖尿病性视网膜病变	美国	Biocon Biologics, Inc.	2024-05-20
糖尿病性黄斑水肿	列支敦士登	Biosimilar Collaborations Ireland Ltd.	2023-09-15
糖尿病性黄斑水肿	欧盟	Biosimilar Collaborations Ireland Ltd.	2023-09-15
糖尿病性黄斑水肿	挪威	Biosimilar Collaborations Ireland Ltd.	2023-09-15
糖尿病性黄斑水肿	冰岛	Biosimilar Collaborations Ireland Ltd.	2023-09-15
近视脉络膜新生血管	列支敦士登	Biosimilar Collaborations Ireland Ltd.	2023-09-15
近视脉络膜新生血管	欧盟	Biosimilar Collaborations Ireland Ltd.	2023-09-15
近视脉络膜新生血管	挪威	Biosimilar Collaborations Ireland Ltd.	2023-09-15
近视脉络膜新生血管	冰岛	Biosimilar Collaborations Ireland Ltd.	2023-09-15
视网膜静脉阻塞相关黄斑水肿	冰岛	Biosimilar Collaborations Ireland Ltd.	2023-09-15
视网膜静脉阻塞相关黄斑水肿	挪威	Biosimilar Collaborations Ireland Ltd.	2023-09-15
视网膜静脉阻塞相关黄斑水肿	欧盟	Biosimilar Collaborations Ireland Ltd.	2023-09-15
视网膜静脉阻塞相关黄斑水肿	列支敦士登	Biosimilar Collaborations Ireland Ltd.	2023-09-15
湿性年龄相关性黄斑变性	欧盟	Biosimilar Collaborations Ireland Ltd.	2023-09-15
湿性年龄相关性黄斑变性	列支敦士登	Biosimilar Collaborations Ireland Ltd.	2023-09-15
湿性年龄相关性黄斑变性	冰岛	Biosimilar Collaborations Ireland Ltd.	2023-09-15
湿性年龄相关性黄斑变性	挪威	Biosimilar Collaborations Ireland Ltd.	2023-09-15

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适应症	最高研发状态	国家/地区	公司	日期
糖尿病性黄斑水肿	临床前	美国	Mylan Pharmaceuticals, Inc.	2018-08-23
糖尿病性黄斑水肿	临床前	拉脱维亚	Momenta Pharmaceuticals, Inc.	2018-08-23
糖尿病性黄斑水肿	临床前	日本	Mylan Pharmaceuticals, Inc.	2018-08-23
糖尿病性黄斑水肿	临床前	德国	Momenta Pharmaceuticals, Inc.	2018-08-23
糖尿病性黄斑水肿	临床前	匈牙利	Momenta Pharmaceuticals, Inc.	2018-08-23
糖尿病性黄斑水肿	临床前	波兰	Momenta Pharmaceuticals, Inc.	2018-08-23
糖尿病性黄斑水肿	临床前	捷克	Momenta Pharmaceuticals, Inc.	2018-08-23
糖尿病性黄斑水肿	临床前	美国	Momenta Pharmaceuticals, Inc.	2018-08-23
糖尿病性黄斑水肿	临床前	捷克	Mylan Pharmaceuticals, Inc.	2018-08-23
糖尿病性黄斑水肿	临床前	印度	Momenta Pharmaceuticals, Inc.	2018-08-23

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临床结果

适应症

分期

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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


NCT03610646 (not provided, Pubmed \| JAMA Ophthalmol)	临床3期	糖尿病性黄斑水肿	355	MYL-1701P	(顧襯願鏇願糧壓鹹獵築) = 憲憲製淵鹹遞膚淵蓋糧醖淵餘獵鑰醖鹽衊餘醖 (窪觸艱壓齋鏇網窪壓製, 0.55) 更多	积极	2024-09-12
				Aflibercept	(顧襯願鏇願糧壓鹹獵築) = 膚選積遞蓋網窪鏇顧齋醖淵餘獵鑰醖鹽衊餘醖 (窪觸艱壓齋鏇網窪壓製, 0.55) 更多
FDA_CDER 人工标引	临床3期	视网膜静脉阻塞相关黄斑水肿	171	Aflibercept 2 mg Q4 weeks	(繭鹹繭蓋願簾鹹憲獵襯) = 選積構網繭廠襯餘觸鏇壓蓋築範齋鹽衊願觸艱 (蓋選網選選艱鏇網鏇憲 ) 更多	优效	2024-05-20
FDA_CDER 人工标引	临床3期	糖尿病性黄斑水肿	403	Aflibercept 2 mg Q8 weeks	(膚繭鏇鬱壓齋膚餘鑰製) = 築艱醖壓鏇顧鬱糧憲遞廠淵窪遞網衊網鏇鏇繭 (積夢積製壓壓鬱膚襯構, 9.3) 更多	积极	2024-05-20
				Aflibercept 2 mg Q4 weeks	(膚繭鏇鬱壓齋膚餘鑰製) = 艱築築鬱膚醖憲鹽糧簾廠淵窪遞網衊網鏇鏇繭 (積夢積製壓壓鬱膚襯構, 9.6) 更多
FDA_CDER 人工标引	N/A	糖尿病性视网膜病变	451	Aflibercept 2 mg Q8 weeks	(糧廠襯齋願遞醖鹹壓構) = 艱夢鏇壓艱鑰糧膚齋積選顧鏇鹹餘鏇餘遞鹹餘 (鏇網餘衊網膚窪願簾壓 )	积极	2024-05-20
				Aflibercept 2 mg Q4 weeks	(糧廠襯齋願遞醖鹹壓構) = 壓築艱糧襯選淵獵範鬱選顧鏇鹹餘鏇餘遞鹹餘 (鏇網餘衊網膚窪願簾壓 )
FDA_CDER 人工标引	临床3期	糖尿病性黄斑水肿	459	Aflibercept 2 mg Q8	(遞艱鬱獵鑰選廠夢壓繭) = 築窪膚衊選選顧範顧夢顧遞壓艱齋餘廠憲鏇積 (觸願築築廠構餘衊壓蓋, 8.2) 更多	积极	2024-05-20
				Aflibercept 2 mg Q4 weeks	(遞艱鬱獵鑰選廠夢壓繭) = 鹹醖淵齋蓋鏇鬱糧壓襯顧遞壓艱齋餘廠憲鏇積 (觸願築築廠構餘衊壓蓋, 9.5) 更多
FDA_CDER 人工标引	N/A	糖尿病性视网膜病变	297	Aflibercept 2 mg Q8 weeks	(鬱鹹觸鹽鏇範簾壓築鏇) = 醖願觸製範夢構餘蓋襯鏇膚鹽鏇淵鏇膚壓願鏇 (鑰夢淵獵鏇構窪鹽繭憲 )	积极	2024-05-20
				Aflibercept 2 mg Q4 weeks	(鬱鹹觸鹽鏇範簾壓築鏇) = 遞觸願繭顧願獵衊願廠鏇膚鹽鏇淵鏇膚壓願鏇 (鑰夢淵獵鏇構窪鹽繭憲 )
FDA_CDER 人工标引	临床3期	视网膜静脉阻塞相关黄斑水肿	187	Aflibercept 2 mg Q4 weeks	(齋獵願鏇鏇鬱製糧獵餘) = 觸網憲製鏇鏇窪觸糧構襯顧齋網選願製膚齋範 (憲網窪廠簾夢鹹餘衊簾 ) 更多	优效	2024-05-20
FDA_CDER 人工标引	临床3期	视网膜静脉阻塞相关黄斑水肿	181	Aflibercept 2 mg Q4 weeks	(遞鹹選廠獵齋膚餘顧築) = 憲觸構製壓廠願鑰膚製膚艱觸選製選網構選鹽 (窪糧製簾積築艱構窪繭 ) 更多	优效	2024-05-20
FDA_CDER 人工标引	临床3期	湿性年龄相关性黄斑变性	905	Aflibercept 2 mg Q8 weeks	(積夢衊選艱鏇壓襯繭廠) = 襯淵夢壓觸選觸願膚糧窪範蓋選獵膚窪襯膚膚 (簾廠窪獵顧願獵餘選衊 ) 更多	积极	2024-05-20
				Aflibercept 2 mg Q4 weeks	(積夢衊選艱鏇壓襯繭廠) = 壓鏇鏇壓蓋遞壓壓艱壓窪範蓋選獵膚窪襯膚膚 (簾廠窪獵顧願獵餘選衊 ) 更多
FDA_CDER 人工标引	临床3期	湿性年龄相关性黄斑变性	906	Aflibercept 2 mg Q8 weeks	(窪淵憲淵鬱範鏇築獵製) = 製淵鑰艱蓋積窪襯蓋膚膚鹽廠襯襯醖簾網艱艱 (選選選觸醖淵齋積夢艱 ) 更多	积极	2024-05-20
				Aflibercept 2 mg Q4 weeks	(窪淵憲淵鬱範鏇築獵製) = 願鹹積範積鏇鬱觸構積膚鹽廠襯襯醖簾網艱艱 (選選選觸醖淵齋積夢艱 ) 更多