Ixekizumab

5月27日，国家药监局药品审评中心（CDE）官网显示，优时比（UCB）申报的比奇珠单抗注射液（商品名：倍捷乐®）两项新适应症上市申请正式获受理，注册分类为3.1类（境外已上市生物制品首次在中国申报上市）。这一动作距离优时比5月12日高调宣布递交申请仅半个月，足见其对中国市场的重视。此次申报的适应症瞄准了中度至重度斑块状银屑病（PSO）及化脓性汗腺炎（HS）两大领域，若顺利获批，将填补国内IL-17双靶点药物在银屑病适应症上的空白，并挑战现有单靶点药物的市场格局。  IL-17赛道从“冷门”到“必争之地”比奇珠单抗的双靶点机制，同时抑制IL-17A和IL-17F两种促炎因子。IL-17A是银屑病、强直性脊柱炎等自免疾病的核心驱动因子，而IL-17F虽研究较少，但两者结构同源性高达55%，在炎症反应中常协同作用。目前，全球已上市的IL-17抑制剂主要分为两类：单靶点（仅抑制IL-17A）和双靶点（同时抑制IL-17A/F）。诺华的司库奇尤单抗（可善挺®）和礼来的依奇珠单抗（拓咨®）属于前者，而优时比的比奇珠单抗则是目前唯一获批的双靶点药物。从机制上看，双靶点设计理论上能更全面地阻断炎症通路，可能带来更持久的疗效。  但是，国内IL-17赛道早已硝烟弥漫。诺华的司库奇尤单抗（Cosentyx）凭借先发优势稳坐头把交椅；礼来的依奇珠单抗（拓咨）则通过灵活定价策略抢占中端市场。国产阵营中，智翔金泰的赛立奇单抗、恒瑞的安达静等产品也在加速布局，且部分已进入医保谈判队列。比奇珠单抗若想破局，仅靠“双靶点”的学术概念显然不够，必须在疗效、安全性或用药便捷性上拿出差异化优势。  银屑病：主战场的新挑战此次申报的PSO适应症是IL-17抑制剂的主战场。目前国内已上市的同类药物普遍采用“密集诱导+维持”的给药方案，例如司库奇尤单抗需在前5个月每周注射，而比奇珠单抗的III期数据显示，其治疗银屑病仅需每8周一次皮下注射，且无需负荷剂量。此外，药物稳定性也是一大卖点，室温25℃下可保存25天，这对需要频繁出差或医疗资源匮乏地区的患者颇具吸引力。  化脓性汗腺炎（HS）：填补国内治疗空白HS是一种慢性炎症性皮肤病，以反复脓肿和窦道形成为特征，国内长期依赖抗生素和手术，缺乏靶向疗法，患者也常因误诊为普通痤疮而延误治疗。全球范围内，仅有两款生物制剂（阿达木单抗和司库奇尤单抗）获批HS适应症，国内更是长期依赖抗生素和手术等传统手段，疗效有限且复发率高。  根据比奇珠单抗的BE HEARD I和BE HEARD II研究结果，在第16周时，接受比奇珠单抗320mg每2周一次（Q2W）治疗的患者中，分别有48%和52%达到HiSCR50（脓肿和炎性结节数量合计减少至少50%，且脓肿或引流通道计数较基线没有增加），而安慰剂组分别为29%和32%。同时，在第16周，BE HEARD I组和BE HEARD II组的比奇珠单抗320mg Q2W患者分别有33%和36%达到HiSCR75（脓肿和炎性结节数量合计减少75%），而安慰剂组分别为18%和16%。这表明比奇珠单抗在减少脓肿和炎性结节数量方面显著优于安慰剂。若成功获批，将可能成为国内首个HS靶向生物制剂，填补治疗空白。不过，HS诊断率低、患者教育不足的现实，也可能导致市场渗透缓慢。优时比需与学会合作推进诊疗标准化，甚至探索皮肤科与外科的多学科协作模式，才能将临床优势转化为市场增量。  机遇与风险并存政策支持方面：2025 年 3 月施行的《生物制品注册受理审查指南》进一步规范了电子申报流程，确实为药企的注册申报提供了更清晰的指引。而“受理靠前服务”机制于2024 年 11 月启动，为包括优时比在内的跨国药企提供了申报前的沟通绿色通道，有利于规避因资料瑕疵导致的延期风险，加速了比奇珠单抗等创新药的申报进程。但挑战同样存在。HS适应症在国内尚无成熟疗效评价体系，可能需要采用国际认可的HiSCR评分标准，这对临床数据的外推性提出更高要求。此外，IL-17抑制剂的长期安全性仍需关注，尽管比奇珠单抗在52周内未报告活动性结核感染，但其对念珠菌感染的诱发风险（约4%）仍高于TNF抑制剂，需在说明书中明确警示。  商业化合作与市场下沉方面，优时比于2024年11月将比奇珠单抗的中国销售权授予博锐生物，后者在自免领域拥有成熟团队和5款上市药物。这一举动可规避自建渠道的高成本，但需要平衡利润分成与市场控制权。此外，参考诺华的“千县无银”项目，下沉县域市场并联合医联体提升可及性或是关键。  双靶点能否改写市场规则？从全球视野看，IL-17赛道已进入“精准分层”时代。司库奇尤单抗凭借银屑病关节炎的广泛适应症构建根基，礼来则通过依奇珠单抗的儿科适应症挖掘增量市场。比奇珠单抗若能在国内复制其海外策略，通过axSpA（中轴型脊柱关节炎）全疾病谱覆盖建立专科医生黏性，再向银屑病、HS等适应症辐射，或许能实现“农村包围城市”的差异化竞争。  另一方面，国产IL-17药物的崛起不可忽视。智翔金泰的赛立奇单抗已进入上市倒计时，其定价可能更具侵略性；恒瑞、信达等企业也在布局双靶点甚至多靶点药物。优时比若不能在未来2-3年内巩固先发优势，恐将陷入“进口药打品牌，国产药拼成本”的被动局面。  比奇珠单抗的此次申报，不仅是优时比在中国自免领域的又一次落子，也折射出跨国药企在“内卷”加剧的背景下，对差异化适应症和机制创新的迫切追求。双靶点机制与全病程覆盖为其提供了差异化武器，但面对国产药物的成本优势和诺华、礼来的市场壁垒，其需在临床价值、可及性与商业策略中找到最佳平衡点。参考来源：[1]https://mp.weixin.qq.com/s/Doybrt3K84Ntj7pKA6a7OA[2]https://mp.weixin.qq.com/s/QNKUwr2iPyqmv1b_UfW4tA药事纵横投稿须知：稿费已上调，欢迎投稿

Advanz Pharma secures exclusive rights from Alvotech to commercialize three biosimilar candidates in Europe in addition to previously partnered programs The agreement includes proposed biosimilars to Ilaris ® (canakinumab), Kesimpta ® (ofatumumab) and an additional early-stage undisclosed biosimilar candidate REYKJAVIK, Iceland and LONDON, May 28, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the companies have entered into an agreement to expand their commercial partnership to cover three additional biosimilar candidates. The new agreement covers the supply and commercialization in Europe of biosimilar candidates to Ilaris ® (canakinumab), a human antibody interleukin-1β blocker indicated for the treatment of various inflammatory diseases, and Kesimpta ® (ofatumumab), a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis, in addition to a third undisclosed biosimilar candidate. Alvotech will be responsible for development and commercial supply and Advanz Pharma will be responsible for registration and commercialization in Europe. The agreement includes development and commercial milestones for the three products, totaling up to US$180 million at current exchange rates (EUR 160 million). In addition, the partners will participate in a revenue share. "We are very pleased to expand our partnership with Advanz Pharma. We now have agreed to launch proposed biosimilars to more than ten reference products in Europe, starting in 2025 and reaching beyond 2030. This new agreement demonstrates the business development potential and value of Alvotech’s growing biosimilars pipeline, that is unrivalled by any other biosimilars developer,” said Róbert Wessman, chairman and CEO of Alvotech. “By adding canakinumab, ofatumumab and another early-stage program to our strategic partnership with Alvotech, Advanz Pharma now holds European commercial rights to proposed biosimilars referencing more than ten originator biologics. Importantly, two of these three new candidates address rare-disease indications, reinforcing our commitment to broaden access to rare disease and specialty medicines. Biosimilars are a cornerstone of our growth strategy and this expanded collaboration positions us to deliver sustainable value for patients and healthcare systems alike,” said Steffen Wagner, CEO, Advanz Pharma. Alvotech and Advanz Pharma previously entered into partnership agreements, signed in 2023, to commercialize proposed biosimilars to Xolair ® (omalizumab), Simponi ® (golimumab), Entyvio ® (vedolizumab), Eylea ® (aflibercept) and Eylea ® HD (aflibercept), Dupixent ® (dupilumab), Taltz ® (ixekizumab) and Tremfya ® (guselkumab). The supply and commercialization agreements cover all 30 member countries of the European Economic Area, as well as the UK and Switzerland. For omalizumab, the agreement additionally includes Canada, Australia, and New Zealand. According to IQVIA, the current addressable market for the proposed biosimilars covered by the partnership agreements between Alvotech and Advanz Pharma in the countries in scope is now at least US$13.8bn. Use of trademarks Simponi ® and Tremfya ® are registered trademarks of Johnson & Johnson Inc. Xolair ® , Ilaris ® and Kesimpta ® are registered trademarks of Novartis AG. Eylea ® is a registered trademark of Regeneron Pharmaceuticals, Inc. Entyvio ® is a registered trademark of Millennium Pharmaceuticals, Inc. Dupixent ® is a trademark and brand of Sanofi Biotechnology. Taltz ® is a registered trademark of Eli Lilly and Company. About Alvotech Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com . None of the information on the Alvotech website shall be deemed part of this press release. About Advanz Pharma Partner of choice in specialty, hospital, and rare disease medicines. Advanz Pharma is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialization partner network. Advanz Pharma’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to our dedicated and highly qualified employees, acting in line with our company values of entrepreneurship, speed, and integrity. Alvotech Forward Looking Statements Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial or operating performance of Alvotech and may include, for example, Alvotech’s expectations regarding future growth, results of operations, performance, future capital and other expenditures, competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory review and interactions, the satisfactory responses to the FDA’s inspection findings and resolution of other deficiencies conveyed following the re-inspection of Alvotech’s manufacturing site, the potential approval, including for AVT02, AVT04, and the product candidates in scope of the partnership with Advanz, by the FDA and other regulatory agencies and commercial launch of its product candidates, the timing of the announcement of clinical study results, the commencement of patient studies, regulatory applications, approvals and market launches, and the estimated size of the total addressable market of Alvotech’s pipeline products. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the ability to reach development milestones under commercial partnership agreements including the partnership with Advanz; (2) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (3) the ability to maintain stock exchange listing; (4) changes in applicable laws or regulations; (5) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (6) Alvotech’s estimates of expenses and profitability; (7) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (10) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (11) the ability of Alvotech or its partners, including Advanz, to gain approval from regulators for planned clinical studies, study plans or sites; (12) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (13) Alvotech’s ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (14) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements, including the partnership with Advanz; (15) Alvotech’s ability, and that of its commercial partners, including Advanz, to execute their commercialization strategy for approved products; (16) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (17) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (18) the potential impact of the ongoing COVID-19 pandemic on the FDA’s review timelines, including its ability to complete timely inspection of manufacturing sites; (19) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, war in Ukraine and global geopolitical tension, and the ongoing and evolving COVID-19 pandemic on the Alvotech’s business, financial position, strategy and anticipated milestones; and (20) other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication. Advanz Pharma Forward Looking Statements Certain statements in this press release are forward-looking statements. These statements may be identified by words such as “anticipate”, "expectation", "belief', "estimate", "plan", "target”, “project”, “will”, “may”, “should” or "forecast" and similar expressions, or by their context. Although ADVANZ believes that these assumptions were reasonable when made, by their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions affecting the industry, intense competition in the markets in which Advanz operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Advanz’s markets, and other factors beyond the control of Advanz. Neither ADVANZ nor any of its directors, officers, employees, advisors, or any other person is under any obligation to update or keep current the information contained in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this press release. Statements contained in this press release regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. No obligation is assumed to update any forward-looking statements. The information contained in this press release is provided as at the date of this document and is subject to change without notice. MEDIA CONTACTS Alvotech Global Communications and Investor Relations Benedikt Stefansson alvotech.ir@alvotech.com Advanz Pharma Global Corporate Communications Courtney Baines Tel: +44 7776 516979 courtney.baines@advanzpharma.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.