Trastuzumab-DKST(Biocon Ltd.)

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.

对于恒瑞来说，近期可谓是冰火两重天。16号晚间，恒瑞发布了一则合作公告：将其GLP-1组合的大中华区以外的全球范围开发、生产和商业化权益给予美国Hercules公司。因此，恒瑞将获得1亿美元里程碑付款，以及有资格获得临床、监管、销售里程碑付款和销售提成。此外，这笔交易创新的一点还在于，作为对价的一部分，恒瑞同时还获得了Hercules公司19.9%的股权。而当利好还没有足够反应到市场上市时，17号傍晚传来一则“噩耗”——“双艾”组合被FDA发了完整回复信（CRL）。这封“拒信”中指出的问题到底有多严重？“双艾”组合还有希望在美上市吗？恒瑞的两羹饭GLP-1组合中包含3个管线，分别为：口服小分子GLP-1受体激动剂HRS-7535；多肽GLP-1/GIP双受体激动剂注射液和口服HRS9531；下一代肠促胰岛素产品HRS-4729。从临床进度来看，HRS-7535和HRS9531都正在进行临床II期研究，预计今年下半年读出结果；而HRS-4729则是一款临床前药物。对于GLP-1来说，当下最热门的适应症无疑是减重。正好，HRS-7535和HRS9531均有所布局，且正如上述所说，很快就能揭晓答案。因此首个问题是，这笔交易值不值？虽然宣称这笔交易总价60亿美元，但是恒瑞确定能拿到手的只有1亿美元首付款。剩下的59亿多美元，以为值钱未知的股权，都得看未来管线的临床进展，可以说是“大饼”一块。现在能用于参考减重效果的只有早期数据。在各自的I期临床中，HRS-7535和HRS9531均表现出一致的减重效果。29天时，HRS-7535将受试者体重较基线减少了4.38公斤（6.63%）；给药4周后，0.9-5.4 mg的HRS9531将平均体重减轻4.3-7.7 kg （6.7%-9.3%），最大减轻8.0kg（10.0%）。减重是千亿大市场。高盛认为，到2030年，全球减重药物市场将会达到1000亿美元左右。而市场普遍预期，届时礼来和诺和诺德将垄断绝大减重市场。礼来的GLP-1/GIP/GCG三靶点激动剂Retatrutide，在48周时将患者体重降低24.2%；GLP-1/GIP双靶点激动剂替尔泊肽在72周时将体重降低22.5%。诺和诺德的Wegovy治疗68周后的数据是-14.9%。除此之外，还有安进、viking等公司的GLP-1管线的强劲加入。可谓战火纷飞。对于值不值的回答，只能等待临床结果的验证。有行业人士估算，即使只有1条成功，也有望能带来60亿美元以上的收益。除此之外，这笔交易新颖的地方还在于结构。恒瑞入了一部分对方公司的股权。交易对象Hercules是一家今年4月份才刚刚成立的新公司。除了恒瑞之外，其他的股东背景都是资本、基金。所以看起来，Hercules更像是个中间商，就等拿到一定临床结果之后，将管线反手卖给MNC。恒瑞早些时候吃过走眼的亏。去年8月，Aiolos以2500万美元首付款和近期里程碑付款，从恒瑞手里拿到了SHR-1905管线。随即5个月后，将其转卖给GSK，赚了9亿多美元的差价。这一次，吸取教训，即使Hercules倒卖，恒瑞也能分得一羹。不止CMC，更严重的问题但是相比之下，出海前辈“双艾”组合却遇到了一些麻烦。“双艾”组合指的是PD-1抑制剂卡瑞利珠单抗和阿帕替尼。去年10月，恒瑞宣布将其肝细胞癌适应症的大中华区和韩国外权益license-out给Elevar公司，交易总金额超6亿美元。根据恒瑞公告，FDA在CRL里主要传达出2层意思：一是CMC的问题，FDA表示会基于企业对生产场地检查缺陷的完整答复进行全面评估；二是临床检查的问题，由于部分国家旅行限制，FDA在审查周期内无法完成必须的临床检查。CRL并不代表药物后续无上市可能性。更贴切的说，它只代表这次审评中FDA发现了问题，且这些问题导致此次申请不能获得批准。问题可大也可小。一般常见：生产现场、质量和稳定性、药物的安全性/功效、仿制药生物同类性、错误的统计数据，以及说明书标签等问题。多数情况下，相比安全性和有效性问题，生产/管理相关问题都是可以修正的。比如说2022年5月，君实也曾收到了一封CRL，要求他们进行一项质控流程变更。随后不久君实生物重新提交了上市申请，并最终于同年11月特瑞普利单抗获批在美上市。恒瑞可能更需要操心的是临床检查问题。“双艾”组合的肝细胞癌III期研究CARES-310，在全球13个国家和地区的95个研究中心开展。共有543名患者参与，他们被随机分配接受“双艾”组合治疗或接受对照组索拉非尼治疗。根据ClinicalTrials.gov，该III期试验在乌克兰设立了8个site，俄罗斯也有13个。CARES-310研究开始于2019年6月28日，主要完成于2022年2月8日。然而不足20天后，俄乌战争爆发了。在这一点上，恒瑞是有一点幸运的，只是这份幸运没有持续太久。同在5月17日，俄罗斯国防部发布消息称，过去一周，俄军共控制了哈尔科夫地区12个定居点。哈尔科夫是乌克兰的第2大城市，而在这里，就有“双艾”组合的两个site。有看到一些人苛责恒瑞去乌克兰做临床试验。但这种苛责是建立在已经发生俄乌战争的现实上来说的。苏联解体后，乌克兰继承了医疗“遗产”——先进的卫生系统、高效的监管审批流程、丰富的临床研究经验以及众多受过GCP标准培训的经验丰富的临床专业人员。FDA和EMA认可乌克兰的研究数据，再加上当地的消费水平，显然——性价比极高。战争爆发时，很多人忧虑在乌克兰进行的临床研究。据悉，乌克兰拥有约2500家公共医疗机构，每年约有500项正在进行的临床试验。乌克兰当时至少有680项正在进行或者计划进行的临床试验，其中大部分是全球多中心药物临床试验。Elevar的韩国母公司HLB表示，这些问题非根本性问题。恒瑞也在公告中表示，将与监管机构保持密切沟通，尽快重新提交上市申请。但何时取消旅行限制，恒瑞也不知道，也无法控制。展望从1970年至今，恒瑞历经50余载风雨磨砺。在集采冲击的几年间，恒瑞经受了由仿到创的转型阵痛。时至今日，集采的影响逐渐消退，未来恒瑞对仿制药的依赖程度有望进一步降低。与此同时，创新管线开始迎来了收获期——截至2024年4月，恒瑞已经有16款1类创新药上市，7款创新药处于NDA阶段，15款药物处于III期临床。此外，恒瑞的出海也可圈可点。在2023年，恒瑞共与多家海外药企达成5项对外授权，交易总金额超40亿美元。其中，与德国默克之间的PARP抑制剂和Claudin 18.2 ADC合作，为恒瑞带来1.6亿欧元预付款以及4000万欧元的技术转移费，总交易金额可达14亿欧元。出海本就不是一件容易事情，有胜有败。在吸取了之前的经验后，我们也可以看到恒瑞在BD交易上的策略成长。好的临床项目就如同金子，一定会发光。参考资料：1.恒瑞公告2.ClinicalTrials.gov.A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC3.《关于CRL我们需要知道什么？》此海非彼海4.《新药周观点：恒瑞最新创新药管线披露，24年有望迎来多个新品种获批》国投证券5.《恒瑞出海交易，不能只看60亿》同写意点击图片，免费GET海量新药信息 👇👇👇