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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100 项与阿柏西普生物类似药(Viatris) 相关的转化医学

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100 项与阿柏西普生物类似药(Viatris) 相关的专利（医药）

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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

Importance:

Biosimilars 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).

Objective:

To compare efficacy and safety of MYL-1701P, an aflibercept biosimilar, with reference aflibercept (Eylea [Regeneron]) in DME.

Design, Setting, and Participants:

This 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.

Interventions:

Formulations 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 Measures:

The 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).

Results:

A 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 Relevance:

MYL-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 Registration:

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

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·Journal of immunopharmacology

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

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）

2025-04-18

·FiercePharma

Fierce Pharma Asia—The latest on Trump's tariffs; Leqembi's EU approval; Kyowa Kirin's biologics plant

Trump's new Section 232 investigation, Leqembi's EU approval, and Kyowa Kirin's $118 million biologics plant made our news this week. The Trump administration is expected to announce tariffs on pharmaceuticals "in the next month or two," an official said. The European Commission has approved Eisai and Biogen's Leqembi in Alzheimer's disease. Kyowa Kirin has finished the build-out of a Japanese biologics plant. And more.1. Trump administration launches national security investigation into pharmaceuticals, paving way for tariffsIn short reprieve for pharma, commerce secretary says drug tariffs to come 'in the next month or two'The Trump administration has launched what’s known as a Section 232 investigation, looking into the national security effects of pharmaceutical imports. Findings from the probe could support tariffs on drugs, which Commerce Secretary Howard Lutnick said will come “in the next month or two.” The Indian Pharmaceutical Alliance warned that generic manufacturers, which are already operating on “razor-thin margins,” can’t bear large tariffs.2. Eisai, Biogen's Alzheimer's med Leqembi wins long-awaited European approvalAfter months of back and forth, Eisai and Biogen’s Leqembi has won the European Commission’s authorization in Alzheimer’s disease. The indication covers certain early-stage patients with mild cognitive impairment. In Europe, the drug's use is restricted to those who have one or no copies of the ApoE4 gene and who have amyloid beta plaques in their brain.3. As work on massive US plant continues, Kyowa Kirin wraps up construction of $118M biologics plant in JapanKyowa Kirin has finished the construction of a new drug substance manufacturing facility at its site in Takasaki, Japan. The 16.8 billion Japanese yen ($118 million) plant will be used to produce investigational biologics for early-stage development. The site also serves as a training facility to help fill Japan’s gap in experienced biopharma production engineers.4. Biocon Biologics lines up US Eylea biosim launch in '26 (Regulatory tracker)Biocon Biologics has reached a deal with Regeneron on the company’s Eylea biosimilar, Yesafili. Approved by the FDA last year, the interchangeable biosimilar can be launched in the U.S. in the second half of 2026 or earlier under certain conditions. Given the settlement, the two firms have moved to dismiss their pending litigations on the subject.5. Daiichi Sankyo inks RNA-targeted neurodegenerative disease deal with Wayfinder (release)Daiichi Sankyo has penned a collaboration with Wayfinder Biosciences to develop RNA-targeting small molecules for a neurodegeneration target. Seattle-based Wayfinder says its platform enables quantitative insights into the binding of small molecules to RNA and their selectivity and function. Financial details were not disclosed.6. Haleon takes full control of famed Chinese consumer health joint venture (Reuters)Haleon paid about 1.62 billion Chinese yuan ($220 million) to obtain the remaining 12% stake in the Chinese joint venture Tianjin TSKF Pharmaceutical. Formed in the 1980s by Smith, Kline & French and Tianjin Pharmaceutical, the consumer health firm marked one of the first foreign-backed drugmakers to enter China. The company is a household name with popular OTC brands such as the Fenbid line of ibuprofen products, and it generated 2024 revenue of 3.56 billion yuan ($490 million).Other News of Note:7. Aurobindo gets Form 483 scolding from FDA at North Carolina inhaler plant8. Daiichi Sankyo celebrates its roots and blooming future at DC cherry blossom festival9. After 5-year delay, CMG Pharma wins FDA nod for oral schizophrenia drug (Korea Biomedical Review)

上市批准

2025-04-15

·PipelineReview

Biocon Biologics Secures Market Entry Date for Yesafili™, an Interchangeable Biosimilar to Eylea®, in the U.S.

BRIDGEWATER, NJ, USA and BENGALURU, Karnataka, India I April 15, 2025 I Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced today a settlement and license agreement with Regeneron that clears the way to commercialize Yesafili™ (aflibercept-jbvf), an interchangeable* biosimilar aflibercept, in the United States. YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor, is used to treat several different types of ophthalmology conditions, is a biosimilar of its reference product EYLEA® (aflibercept). Biocon Biologics and Regeneron executed the settlement agreement to dismiss the pending appeal at the United States Court of Appeals for the Federal Circuit (USCAFC) of patent US11084865 (‘865 patent) and the pending litigation at the U.S. District Court for the Northern District of West Virginia, Clarksburg Division. Biocon Biologics announced a settlement and license agreement with Regeneron for a biosimilar Aflibercept This agreement enables the Company to launch in the United States in the second half of calendar year 2026 or earlier in certain circumstances. The terms of the settlement are confidential. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., said: “This settlement clears the path for Biocon Biologics to be among the first to bring a reliable, high-quality aflibercept biosimilar to patients and healthcare providers in the United States. As the first-to-file interchangeable biosimilar to Eylea®, YESAFILI affirms our scientific strength and marks our strategic entry into Ophthalmology, expanding our footprint in the U.S. and advancing our mission to increase access to life-changing treatments.” Previously, the U.S. Food and Drug Administration (U.S. FDA) approved Yesafili™ (aflibercept-jbvf) , an interchangeable* biosimilar aflibercept in May 2024. Additionally, Biocon Biologics secured a settlement agreement in Canada with Bayer Inc. and Regeneron Pharmaceuticals, Inc., for the launch of YESAFILI™ no later than July 1, 2025. YESAFILI is intended for the treatment of neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV). It is highly similar to the reference product Eylea® (aflibercept). Data shows that YESAFILI has comparable quality, safety, and efficacy to Eylea®. *An interchangeable product (IP) is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product (RP) and that there are no clinically meaningful differences between the products; it can be expected to produce the same clinical result as the RP in any given patient; and if administered more than once to a patient, the risk in terms of safety or diminished efficacy from alternating or switching between use of the RP and IP is not greater than that from the RP without such alternation or switch. Interchangeability of YESAFILI has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. About YESAFILI: The approval for YESAFILI (aflibercept-jbvf) was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that YESAFILI is highly similar to Eylea®. In a Phase 3 INSIGHT Study, YESAFILI was compared with Eylea® in patients with Diabetic Macular Edema. Study demonstrated that there were no clinically meaningful differences between YESAFILI and Eylea in terms of pharmacokinetics, safety, efficacy, and immunogenicity. INDICATIONS AND USAGE: YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL) , a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its ‘lab to market’ capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. Biocon Biologics has commercialized nine biosimilars from its pipeline of 20 products in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. Its pipeline has several biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. The Company has many ‘firsts’ to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website www.bioconbiologics.com ; Follow us on X (formerly Twitter ): @BioconBiologics and LinkedIn : Biocon Biologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: www.biocon.com ; Follow-us on X (formerly Twitter ) @bioconlimited and LinkedIn : Biocon for company updates. SOURCE: Biocon Biologics

上市批准引进/卖出临床3期临床结果

2025-03-24

·生物谷

重磅！2025年10大药物专利即将到期，市场独占权保卫战开启，涉及强生、再生元、诺华、阿斯利康等

每年，制药行业都会迎来一系列重磅药物的专利到期，这一现象被称为“专利悬崖”。2025年，这一悬崖尤为引人注目，多款年销售额数十亿美元的药物将面临生物类似药和仿制药的激烈竞争。这不仅对制药公司的财务状况构成挑战，也为患者带来了更多的治疗选择和潜在的价格下降。 1. Stelara（乌司奴单抗）：强生的免疫学重磅药物适应症：银屑病关节炎、斑块型银屑病、克罗恩病、溃疡性结肠炎公司：强生 2024年美国销售额：67.2亿美元 Stelara是强生的免疫学重磅药物，主要用于治疗银屑病关节炎、斑块型银屑病、克罗恩病和溃疡性结肠炎。2024年，Stelara在美国的销售额高达67.2亿美元，成为自2023年艾伯维的Humira专利到期以来，美国市场最大的专利悬崖事件。尽管强生通过一系列法律和解协议成功延长了Stelara的市场独占权，但2025年将有多款生物类似药上市，竞争将异常激烈。强生对Stelara的未来表现仍持乐观态度。公司CEO Joaquin Duato在财报电话会议上表示，尽管面临生物类似药的竞争，强生预计2025年仍能实现3%的年增长率。强生还计划通过推广其新一代免疫学药物Tremfya来弥补Stelara的收入损失。Tremfya目前已获批用于银屑病关节炎和斑块型银屑病，并正在申请扩展至克罗恩病适应症。强生全球创新药物主席Jennifer Taubert指出，Humira的市场侵蚀曲线可能是预测Stelara专利悬崖的最佳模型。 2. Eylea（阿柏西普）：再生元的眼科药物适应症：湿性年龄相关性黄斑变性、糖尿病性黄斑水肿、视网膜静脉阻塞、早产儿视网膜病变、糖尿病性视网膜病变公司：再生元 2024年美国销售额：47.7亿美元 Eylea是再生元的眼科药物，主要用于治疗湿性年龄相关性黄斑变性、糖尿病性黄斑水肿等眼部疾病。2024年，Eylea在美国的销售额为47.7亿美元。然而，Eylea的销售增长已经因罗氏的Vabysmo竞争而停滞。Vabysmo自2022年推出以来，迅速抢占市场份额，2024年销售额超过40亿美元。随着生物类似药的上市，Eylea的销售压力将进一步加大。2024年11月，安进在美国推出了首款Eylea生物类似药Pavblu，上市后前九周销售额即达到3100万美元。再生元还面临来自其他生物类似药的竞争，包括Biocon的Yesafili和Biogen与Samsung Bioepis的Opuviz。再生元计划通过提升其长效版本Eylea HD的市场地位来应对竞争。再生元CEO Len Schleifer博士表示，Eylea HD是Eylea的重大进步，但仍需更多支持以对抗Vabysmo和生物类似药的竞争。图片来源自：千库网 3. Prolia/Xgeva（地舒单抗）：安进的骨科药物适应症：高骨折风险的骨质疏松症、前列腺癌或乳腺癌患者接受激素消融治疗的骨质流失；预防癌症骨转移患者的骨骼相关事件、骨巨细胞瘤、恶性肿瘤高钙血症公司：安进 2024年美国销售额：43.9亿美元 Prolia和Xgeva是安进的重磅骨科药物，主要用于治疗骨质疏松症和预防癌症骨转移患者的骨骼相关事件。2024年，这两款药物在美国的销售额合计为43.9亿美元，其中Prolia销售额为43.7亿美元，同比增长8%，Xgeva销售额为22.3亿美元，同比增长5%。然而，随着生物类似药的上市，安进将面临市场份额的侵蚀。2024年3月，Sandoz率先获得FDA批准，推出首款可互换的Prolia和Xgeva生物类似药Jubbonti和Wyost。安进已与多家生物类似药开发商达成和解，以延缓竞争。例如，安进与Celltrion达成协议，允许后者在2025年6月1日或更早推出其denosumab生物类似药。尽管面临竞争，安进仍通过其强大的生物类似药业务和多元化产品组合来应对挑战。 4. Entresto（沙库巴曲/缬沙坦）：诺华的心力衰竭药物适应症：心力衰竭公司：诺华 2024年美国销售额：40.5亿美元 Entresto是诺华的心力衰竭治疗药物，2024年在美国的销售额为40.5亿美元。尽管诺华正在为仿制药的竞争做准备，但其关键组合专利将于2025年7月到期，预计将在2025年中期失去美国市场独占权。诺华已与多家仿制药商达成和解，但仍面临来自Torrent、Dr. Reddy’s Laboratories等公司的竞争。诺华CEO Vas Narasimhan表示，Entresto的仿制药竞争是不可避免的，但公司已通过多元化产品线和市场策略做好了准备。此外，Entresto是首批受《通胀削减法案》Medicare谈判定价影响的药物之一。Narasimhan认为，尽管价格削减可能对收入产生影响，但公司已规划了其他收入来源以应对这一挑战。 5. Soliris（依库组单抗）：阿斯利康的罕见病药物适应症：阵发性夜间血红蛋白尿、非典型溶血性尿毒症综合征、全身性重症肌无力、视神经脊髓炎谱系障碍公司：阿斯利康 2024年美国销售额：15.2亿美元 Soliris是阿斯利康的罕见病药物，主要用于治疗阵发性夜间血红蛋白尿和非典型溶血性尿毒症综合征。2024年，Soliris在美国的销售额为15.2亿美元。随着生物类似药的上市，Soliris的销售将面临压力。安进的Soliris生物类似药Bkemv已于2024年获得FDA批准，并计划在2025年第二季度上市。阿斯利康通过其后续药物Ultomiris来应对Soliris的专利悬崖。Ultomiris于2018年获批，用于治疗与Soliris相同的疾病，并在2024年以39亿美元的销售额超过了Soliris的25.9亿美元。阿斯利康希望凭借Soliris、Ultomiris以及新获批的Voydeya，继续在罕见病市场保持主导地位。图片来源自：千库网 6. Promacta（艾曲波帕）：诺华的血小板减少症药物适应症：血小板减少症、再生障碍性贫血公司：诺华 2024年美国销售额：11.8亿美元 Promacta是诺华的血小板减少症治疗药物，2024年在美国的销售额为11.8亿美元。诺华预计Promacta将在2025年中期失去美国市场独占权。2024年4月，FDA批准了Annora的首个Promacta仿制药，并授予其180天的市场独占期。 Promacta自2008年获批以来，逐渐成为诺华的重磅药物之一。2024年，Promacta的全球销售额达到22亿美元，其中美国市场贡献了12亿美元。诺华计划通过扩展Promacta的适应症和市场推广来应对仿制药的竞争。 7. Simponi/Simponi ARIA（戈利木单抗）：强生的免疫学药物适应症：类风湿性关节炎、银屑病关节炎、强直性脊柱炎、溃疡性结肠炎、多关节型青少年特发性关节炎公司：强生 2024年美国销售额：10.8亿美元 Simponi是强生的免疫学药物，主要用于治疗类风湿性关节炎、银屑病关节炎等疾病。2024年，Simponi在美国的销售额为10.8亿美元。随着生物类似药的上市，Simponi的销售将面临挑战。Teva和Alvotech的Simponi生物类似药AVT05预计将在2025年第四季度获得FDA批准。强生计划通过扩展Simponi的适应症来应对竞争。2024年12月，强生向FDA提交了扩展Simponi标签的申请，以包括儿童溃疡性结肠炎的适应症。尽管面临竞争，Simponi仍然是强生免疫学产品线中的重要组成部分。 8. Tysabri（那他珠单抗）：渤健的多发性硬化症药物适应症：多发性硬化症、克罗恩病公司：渤健 2024年美国销售额：9.2亿美元 Tysabri是渤健的多发性硬化症药物，2024年在美国的销售额为9.2亿美元。渤健正在为生物类似药的竞争做准备，预计2025年将有多款生物类似药上市。山德士的Tysabri生物类似药Tyruko已于2023年获得FDA批准，但上市时间被推迟至2025年。渤健通过其JCV抗体检测STRATIFY来评估Tysabri的使用风险，并计划通过新产品推出应对竞争。尽管Tysabri的销售额已从2021年的峰值下降，但它仍然是渤健多发性硬化症业务的重要驱动力。图片来源自：千库网 9. Tasigna（尼罗替尼）：诺华的慢性髓性白血病药物适应症：慢性髓性白血病公司：诺华 2024年美国销售额：8.48亿美元 Tasigna是诺华的慢性髓性白血病治疗药物，2024年在美国的销售额为8.48亿美元。诺华预计Tasigna将在2025年中期失去美国市场独占权。Apotex、MSN Laboratories等公司已获得Tasigna仿制药的临时FDA批准。 Tasigna自2007年获批以来，逐渐成为诺华的重磅药物之一。2024年，Tasigna的全球销售额为17亿美元，同比下降8%。诺华计划通过多元化产品线和市场策略应对仿制药的竞争。 10. Brilinta（倍林达）：阿斯利康的抗凝血药物适应症：急性冠状动脉综合征、冠状动脉疾病、急性缺血性卒中或高危短暂性脑缺血发作公司：阿斯利康 2024年美国销售额：7.51亿美元除了SGLT2抑制剂Farxiga之外，抗凝血药物Brilinta曾是阿斯利康推出的一款重要心血管代谢药物，旨在帮助公司在其明星药物Crestor失去专利独占权后实现业务增长。 Brilinta于2011年首次获得美国食品药品监督管理局（FDA）批准，用于降低经历过急性冠状动脉综合征（如心脏病发作）的患者发生二次心血管事件的风险。2015年，该药物的适应证扩展为P2Y12受体拮抗剂，这一扩展为其开辟了更广阔的市场，使其能够用于超过第一年的长期治疗。2020年，Brilinta又获得了两次重要的适应证扩展：一是被批准用于降低某些高危患者首次心脏病发作或中风的风险；二是在两组中风患者中获批使用，进一步巩固了其在心血管疾病治疗领域的地位。然而，Brilinta的发展并非一帆风顺。2016年，该药物在针对周围动脉疾病（PAD）的两项3期临床试验Socrates和Euclid中遭遇挫折。在Socrates试验中，Brilinta在预防新中风、心脏病发作或死亡方面未能优于阿司匹林；而在Euclid试验中，Brilinta也未能优于百时美施贵宝和赛诺菲的知名药物Plavix，以预防主要不良心血管事件。 2014年，阿斯利康首席执行官Pascal Soriot成功抵御了辉瑞的敌意收购，并为Brilinta设定了到2023年实现35亿美元的销售目标。然而，由于PAD试验的失败，公司不得不承认这一目标已不再可实现。事实上，Brilinta从未达到35亿美元的销售目标，其全球销售额在2020年达到峰值，仅为15.9亿美元。此外，COVID-19疫情对心脏相关住院的影响，以及中国实施的一种名为“基于量的采购”（VBP）的药品降价计划，使得Brilinta原本强劲的销售增长提前结束。如今，预计仿制药将在2025年进入美国市场。在2025年2月的阿斯利康第四季度电话会议中，Soriot表示，尽管预计Brilinta将失去专利独占权，且Farxiga和roxadustat可能被纳入VBP，但公司仍期待在2025年实现又一年的强劲表现。为了捍卫Brilinta的市场地位，自2015年以来，阿斯利康一直在与仿制药商展开激烈的法庭斗争。根据其过去的年度报告，这家英国制药巨头在2020年达成了三次单独的和解协议，随后在2022年和2024年又达成了更多和解。根据FDA的橙皮书，Brilinta的主要监管市场独占期将于5月9日到期，此外还有六个月的儿科市场独占期，延续至11月9日。阿斯利康自身也将2025年列为该药物关键专利的到期年份。在去年的一份报告中，药品福利管理公司OptumRx预测，阿斯利康的Brilinta的首批美国仿制药将在5月上市。参考资料： The top 10 drugs losing US exclusivity in 2025 本文仅用于学术分享，转载请注明出处。若有侵权，请联系微信：bioonSir 删除或修改！点击下方「阅读原文」，前往生物谷官网查询更多

生物类似药专利到期财报

100 项与阿柏西普生物类似药(Viatris) 相关的药物交易

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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
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	欧盟	Biocon Biologics Ireland Ltd.	2023-09-15
糖尿病性黄斑水肿	冰岛	Biocon Biologics Ireland Ltd.	2023-09-15
糖尿病性黄斑水肿	列支敦士登	Biocon Biologics Ireland Ltd.	2023-09-15
糖尿病性黄斑水肿	挪威	Biocon Biologics Ireland Ltd.	2023-09-15
近视脉络膜新生血管	欧盟	Biocon Biologics Ireland Ltd.	2023-09-15
近视脉络膜新生血管	冰岛	Biocon Biologics Ireland Ltd.	2023-09-15
近视脉络膜新生血管	列支敦士登	Biocon Biologics Ireland Ltd.	2023-09-15
近视脉络膜新生血管	挪威	Biocon Biologics Ireland Ltd.	2023-09-15
视网膜静脉阻塞相关黄斑水肿	欧盟	Biocon Biologics Ireland Ltd.	2023-09-15
视网膜静脉阻塞相关黄斑水肿	冰岛	Biocon Biologics Ireland Ltd.	2023-09-15
视网膜静脉阻塞相关黄斑水肿	列支敦士登	Biocon Biologics Ireland Ltd.	2023-09-15
视网膜静脉阻塞相关黄斑水肿	挪威	Biocon Biologics Ireland Ltd.	2023-09-15
湿性年龄相关性黄斑变性	欧盟	Biocon Biologics Ireland Ltd.	2023-09-15
湿性年龄相关性黄斑变性	冰岛	Biocon Biologics Ireland Ltd.	2023-09-15
湿性年龄相关性黄斑变性	列支敦士登	Biocon Biologics Ireland Ltd.	2023-09-15
湿性年龄相关性黄斑变性	挪威	Biocon Biologics Ireland Ltd.	2023-09-15

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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


NCT03610646 (not provided, Pubmed \| JAMA Ophthalmol)	临床3期	糖尿病性黄斑水肿	355	MYL-1701P	膚鬱糧憲積糧糧窪願觸(餘選夢膚鏇簾築網簾製) = 淵鹹選範艱網襯蓋構獵鏇網鹽餘餘鹽範簾觸襯 (艱窪餘顧齋艱廠繭簾網, 0.55) 更多	积极	2024-09-12
				Aflibercept	膚鬱糧憲積糧糧窪願觸(餘選夢膚鏇簾築網簾製) = 鑰製構艱選製繭繭蓋遞鏇網鹽餘餘鹽範簾觸襯 (艱窪餘顧齋艱廠繭簾網, 0.55) 更多
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	觸鑰遞遞齋繭願選衊簾(範構繭築鹽艱繭鏇蓋鬱) = 觸鹹遞願顧範餘憲齋鹽獵積夢襯糧蓋築顧積襯 (糧蓋艱積範糧積醖積淵 ) 更多	积极	2024-05-20
				Aflibercept 2 mg Q4 weeks	觸鑰遞遞齋繭願選衊簾(範構繭築鹽艱繭鏇蓋鬱) = 鬱簾鹹製鬱繭襯構遞齋獵積夢襯糧蓋築顧積襯 (糧蓋艱積範糧積醖積淵 ) 更多
FDA_CDER 人工标引	临床3期	糖尿病性黄斑水肿	459	Aflibercept 2 mg Q8	鏇廠顧鹹顧鹹淵製齋鏇(廠窪膚夢鑰鹽廠範獵鹹) = 鹽製餘壓獵醖鹹淵襯鬱鹽餘獵膚積製願襯簾積 (齋獵網鹽構衊製鑰壓積, 8.2) 更多	积极	2024-05-20
				Aflibercept 2 mg Q4 weeks	鏇廠顧鹹顧鹹淵製齋鏇(廠窪膚夢鑰鹽廠範獵鹹) = 鬱鹹艱鹹遞遞齋願憲願鹽餘獵膚積製願襯簾積 (齋獵網鹽構衊製鑰壓積, 9.5) 更多
FDA_CDER 人工标引	临床3期	糖尿病性黄斑水肿	403	Aflibercept 2 mg Q8 weeks	繭構獵鬱艱簾鹽簾醖齋(鬱齋淵膚範廠憲壓選範) = 醖醖範遞壓艱襯蓋襯觸鏇遞製願遞淵簾願鬱齋 (醖製糧獵鬱窪繭廠範鬱, 9.3) 更多	积极	2024-05-20
				Aflibercept 2 mg Q4 weeks	繭構獵鬱艱簾鹽簾醖齋(鬱齋淵膚範廠憲壓選範) = 廠觸觸艱積夢鑰艱餘鏇鏇遞製願遞淵簾願鬱齋 (醖製糧獵鬱窪繭廠範鬱, 9.6) 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	選築製範蓋範齋積觸餘(夢齋觸襯襯遞鬱壓鏇齋) = 鹽網蓋醖顧膚簾憲衊衊襯憲願壓鹽憲鹽簾鑰醖 (鬱窪憲窪選衊獵簾糧襯 )	积极	2024-05-20
				Aflibercept 2 mg Q4 weeks	選築製範蓋範齋積觸餘(夢齋觸襯襯遞鬱壓鏇齋) = 積齋衊網襯壓鏇餘壓憲襯憲願壓鹽憲鹽簾鑰醖 (鬱窪憲窪選衊獵簾糧襯 )
FDA_CDER 人工标引	N/A	糖尿病性视网膜病变	451	Aflibercept 2 mg Q8 weeks	製蓋觸蓋選膚製糧鑰醖(膚膚鹹鏇醖壓簾夢製醖) = 衊簾廠繭襯願糧憲鹽糧構構範繭膚遞壓鹹構獵 (淵簾衊鏇淵憲糧鏇範觸 )	积极	2024-05-20
				Aflibercept 2 mg Q4 weeks	製蓋觸蓋選膚製糧鑰醖(膚膚鹹鏇醖壓簾夢製醖) = 窪選顧襯淵繭襯艱獵願構構範繭膚遞壓鹹構獵 (淵簾衊鏇淵憲糧鏇範觸 )
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	鹽餘願觸鹹蓋憲積窪鹽(醖衊壓網壓選衊鬱廠膚) = 鏇餘齋窪膚夢鑰積鹽構壓獵願選餘遞範鹹鑰構 (製夢衊鹹醖鬱憲糧襯齋 ) 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	906	Aflibercept 2 mg Q8 weeks	窪艱淵願觸鏇壓鏇鏇顧(構鹹糧壓顧鬱網鏇鏇蓋) = 糧遞積願餘製網齋築餘繭艱範窪積襯蓋夢鑰鹹 (遞襯餘鑰廠淵醖簾憲憲 ) 更多	积极	2024-05-20
				Aflibercept 2 mg Q4 weeks	窪艱淵願觸鏇壓鏇鏇顧(構鹹糧壓顧鬱網鏇鏇蓋) = 壓糧觸遞窪齋蓋觸鹹鬱繭艱範窪積襯蓋夢鑰鹹 (遞襯餘鑰廠淵醖簾憲憲 ) 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	獵壓顧選鏇廠衊鹽鬱艱(簾鑰鬱廠網鏇範壓構鏇) = 齋醖積製簾鑰淵窪鑰積選鏇範願築蓋繭糧積網 (廠蓋憲網獵鬱膚鬱壓襯 ) 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	187	Aflibercept 2 mg Q4 weeks	糧築齋構製築淵蓋廠壓(鑰衊膚衊願鏇網憲鹹鹽) = 選鹽夢餘遞艱鑰構夢築鏇製衊襯築製積糧積鹽 (壓願繭鹹願願築繭淵積 ) 更多	优效	2024-05-20