Trastuzumab-DKST(Biocon Ltd.)

精彩内容 米内网数据显示，2024第一季度中国零售药店终端（城市实体药店+网上药店）药品销售额超过950亿元，其中化学药占比超过50%，中成药占比超过40%，生物药占比超过8%。化学药TOP20中，抗ED药亮了，流感“神药”跌落；中成药TOP20中，11个独家品种霸榜，扬子江2大品种大涨；生物药TOP20中，单抗药物“称王”，重磅注射剂暴涨260%。 近年来中国零售药店终端药品（化药+生物药+中药）销售情况（单位：万元）来源：米内网格局数据库 化学药：抗ED药亮了，流感“神药”跌落 近年来，中国零售药店终端化学药销售额逐年上涨，2024年第一季度超过470亿元，占药品总销售额比重超过50%。 TOP20一级集团中，阿斯利康、拜耳、华润医药、晖致、赫力昂依次位列前五。从销售额增速看，阿斯利康、诺华、石药、辉瑞、豪森、齐鲁均超10%。 TOP20产品均为非独家产品，枸橼酸西地那非片、维生素D滴剂、葡萄糖酸钙锌口服溶液依次位列前三。其中，枸橼酸西地那非片以超12亿元领跑，维生素D滴剂、葡萄糖酸钙锌口服溶液均为营养素补充剂，分别属于维生素类、矿物质补充剂。 2024Q1中国零售药店终端化学药TOP20产品来源：米内网综合数据库 从销售额增速看，11个品种呈正增长，复方氨酚烷胺片、碳酸钙D3片(Ⅰ)涨幅均超过60%，其中复方氨酚烷胺片首次跻身TOP20产品；枸橼酸西地那非片、他达拉非片近年来持续正增长。9个负增长的品种中，磷酸奥司他韦颗粒、磷酸奥司他韦胶囊均为抗流感药，其中磷酸奥司他韦颗粒大幅下滑57.27%。 枸橼酸西地那非片、他达拉非片均为5型磷酸二酯酶的抑制剂，用于治疗男性性功能勃起障碍。近年来，上述2款抗ED药物在中国零售药店终端的销售额逐年上涨，2023年分别超过51亿元、28亿元。在品牌效应加持下，目前2款药物在零售药店的市场均由原研厂家占据主导地位。 近年来中国零售药店终端枸橼酸西地那非片、他达拉非片销售情况（单位：万元）来源：米内网格局数据库 中成药：11个独家品种霸榜，扬子江2大品种大涨 2024年第一季度中国零售药店终端中成药销售额超过390亿元，占药品总销售额比重超过40%。 TOP20一级集团中，华润医药、广药集团、国药集团、北京同仁堂、云南白药依次位列前五。从销售额增速看，扬子江药业、京都念慈菴总厂、福牌阿胶、济川药业均超20%。 TOP20产品中，阿胶以超15亿元蝉联榜首，安宫牛黄丸以超14亿元紧接在后，感冒灵颗粒以超10亿元排位第三。感冒灵颗粒、蒲地蓝消炎片、蓝芩口服液、苏黄止咳胶囊、蒲地蓝消炎口服液销售额增速分别达55.58%、60.32%、67.49%、70.81%、47.38%。 2024Q1中国零售药店终端中成药TOP20产品注：标红为销售额增速超10%来源：米内网综合数据库 11个为独家品种（含独家剂型），其中扬子江药业的蓝芩口服液及苏黄止咳胶囊、京都念慈菴总厂的京都念慈菴蜜炼川贝枇杷膏、漳州片仔癀药业的片仔癀、国药集团的急支糖浆、济川药业的蒲地蓝消炎口服液等品种涨幅均超过10%。 蓝芩口服液、苏黄止咳胶囊均为国家医保乙类品种，且均属于呼吸系统中成药。近年来，苏黄止咳胶囊在中国零售药店终端均以两位数的增速持续扩容，2023年突破6亿元，2024年第一季度大涨70.81%，全年销售额有望再创新高；蓝芩口服液的销售额则有所波动，2022-2023年均超11亿元，2024年第一季度大涨67.49%。 近年来中国零售药店终端蓝芩口服液、苏黄止咳胶囊销售情况（单位：万元）来源：米内网格局数据库 生物药：单抗药物“称王”，重磅注射剂暴涨260% 近年来，中国零售药店终端生物药销售额均以两位数的增速逐年上涨，2024年第一季度超过82亿元，占药品总销售额比重超过8%。 TOP20一级集团中，诺和诺德、罗氏、默沙东、康方生物、诺华依次位列前五。从销售额增速看，诺和诺德、康方生物、正大制药均超60%，其中正大制药涨超180%。 TOP20产品中，人血白蛋白稳居首位，销售额超过6亿元；司美格鲁肽注射液以超5亿元紧接在后，较2023年提升1个位次；帕博利珠单抗注射液以超4亿元排位第三。 2024Q1中国零售药店终端生物药TOP20产品来源：米内网综合数据库 从销售额增速看，12个品种同比增长超过10%，诺和诺德的司美格鲁肽注射液以260.67%的增速领跑，康方药业的卡度尼利单抗注射液涨幅达61.13%，注射用重组人凝血因子Ⅷ、信迪利单抗注射液涨幅均超过50%。 司美格鲁肽注射液是由诺和诺德研发的一款新型长效胰高糖素样肽-1(GLP-1)类似物，2021年4月获批进入中国市场，2023年在中国零售药店终端的销售额超过12亿元，2024年一季度同比增长260.67%。目前国内已有超过20家企业在布局司美格鲁肽生物类似药，其中杭州九源基因、丽珠集团新北江制药等企业的产品已报产在审。 近年来中国零售药店终端司美格鲁肽注射液销售情况（单位：万元）来源：米内网格局数据库 从药物类型看，20个产品中有15个为抗体药物，除了贝伐珠单抗注射液、注射用曲妥珠单抗、阿达木单抗注射液、利妥昔单抗注射液外，其余均为独家品种，包括4款国产创新药及7款进口原研药。 卡度尼利单抗是首个获批上市的国产双抗，也是全球首款获批的PD-1/CTLA-4双特异性抗体。该产品于2022年6月底获批上市，2023年在中国零售终端的销售额就突破10亿元，2024年一季度同比增长61.13%。 近年来中国零售药店终端卡度尼利单抗注射液销售情况（单位：万元）来源：米内网格局数据库 注：米内网《中国城市实体药店药品终端竞争格局》，统计范围是：全国地级及以上城市实体药店，不含县乡村药店；《中国网上药店药品终端竞争格局》，统计范围是：全国网上药店所有药品数据，包括天猫、京东等第三方平台及私域平台上所有网上药店药品数据；上述销售额均以产品在终端的平均零售价计算。 本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

BRIDGEWATER, N.J. and BENGALURU, India, May 21, 2024 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (US FDA) has approved the Company's first-to-file application for Yesafili™ (aflibercept-jbvf), an interchangeable* biosimilar aflibercept. YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor used to treat several different types of ophthalmology conditions, is a biosimilar of its reference product EYLEA® (aflibercept). Continue Reading 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®. The FDA approval of YESAFILI as the first interchangeable biological product to Eylea is a significant milestone. Post this The approval of YESAFILI marks Biocon Biologics' expansion into the ophthalmology therapeutic area in the United States following a steady track record of approval in Europe (September 2023) and the United Kingdom (November 2023) where it was the first biosimilar aflibercept to be approved. The Company has secured a launch date in Canada of no later than July 1, 2025, under the terms of a settlement agreement. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd. , said: "The FDA approval of YESAFILI (aflibercept) as the first interchangeable biological product to Eylea is a significant milestone for Biocon Biologics marking our entry into Ophthalmology, a new therapeutic area in the United States. YESAFILI is approved for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy. This approval builds on our successful track record of bringing the first interchangeable insulin, SEMGLEE®, the first biosimilar Trastuzumab, OGIVRI®, and the first biosimilar Pegfilgrastim, FULPHILA®, to patients in the United States." Matt Erick, Chief Commercial Officer of Advanced Markets, Biocon Biologics Ltd , said: "Biosimilars are crucial for making healthcare more affordable and accessible. YESAFILI will offer ophthalmologists an important new option for patients impacted by macular degeneration and diabetic retinopathy, from a company with a long history of delivering high-quality, science-driven medicines, solely focused on the development and commercialization of biosimilars." There are 19.8 million Americans living with age-related macular degeneration (AMD) in the United States.1 In the U.S., sales of aflibercept were approximately $5.89 billion in 2023.2 Biocon Biologics is a leading global company offering a large portfolio of monoclonal antibodies, insulins, and conjugated proteins. It has achieved several "firsts" in the industry including the first to receive approval in the United States of a biosimilar trastuzumab (OGIVRI®, trastuzumab-dkst) and a biosimilar pegfilgrastim (FULPHILA®, pegfilgrastim-jmdb). Serving over 5.5M patients annually, Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including four in the United States and six in Canada, with a robust pipeline of 20 biosimilar assets spanning multiple therapy areas. 1 Rein DB, Wittenborn JS, Burke-Conte Z, Gulia R, Robalik T, Ehrlich JR, Lundeen EA, Flaxman AD. Prevalence of Age-Related Macular Degeneration in the United States in 2019. JAMA Ophthalmology. Published Online: November 3, 2022 at: . Accessed April 29, 2024. 2 Regeneron Fourth Quarter and Full Year 2023 Financial and Operating Results. February 2, 2024. * 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: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) WARNINGS AND PRECAUTIONS: YESAFILI is contraindicated in patients with Ocular or periocular infection, Active intraocular inflammation and Hypersensitivity to aflibercept. Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately. Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. Please refer to full Prescribing Information for YESAFILI for more information. To report SUSPECTED ADVERSE REACTIONS, contact Biocon Biologics at 1-833-986-1468 or FDA at 1-800-FDA-1088 or . About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives by enabling affordable access to high quality biosimilars for millions of patients worldwide. It 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. BBL has integrated the acquired global biosimilars business of its long-standing partner Viatris, which is a historic milestone in its value creation journey. Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. The Company has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. It has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, BBL is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website: ; Follow us on 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: ; Follow-us on Twitter: @bioconlimited for company updates. Forward-Looking Statements: Biocon This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release. YESAFILI™ is a trademark of a Biosimilars Newco Limited, a Biocon Biologics Ltd. company. OGIVRI® and FULPHILA® are registered trademarks of Biosimilars Newco Limited, a Biocon Biologics Ltd. company. All other trademarks, registered or unregistered, are the property of their respective owners. SOURCE Biocon Biologics Ltd.