Golimumab

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.

▲8月1-2日 2025生物医药创新博览会 扫码报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。5月23日，百奥泰生物制药股份有限公司（以下简称“百奥泰”）发布公告称，其自主研发的BAT2206（乌司奴单抗）注射液正式获得美国食品药品监督管理局（FDA）批准上市，商品名为STARJEMZA，适应症覆盖成人与儿童的中重度斑块状银屑病、活动性银屑病关节炎、克罗恩病及溃疡性结肠炎等。这是继今年5月该药物在中国国家药品监督管理局（NMPA）和欧洲药品管理局（EMA）的上市申请获得受理后，中国生物类似药“出海”的又一突破。从原研药到生物类似药乌司奴单抗的原研药为强生公司的Stelara（喜达诺），其作用机制是通过靶向IL-12和IL-23共有的p40亚基，阻断炎症信号传导，从而治疗自身免疫性疾病。自2009年上市以来，Stelara凭借长效性和广泛的适应症覆盖，成为全球自免领域的重磅药物，2023年全球销售额高达108.58亿美元，2024年虽略有下滑仍达103.61亿美元。然而，随着原研药专利到期，生物类似药的竞争逐渐升温。BAT2206作为Stelara的生物类似药，其开发严格遵循中美欧的指导原则，通过药学、非临床和临床数据的全面比对，证明了与原研药的高度相似性。从临床需求来看，银屑病等自身免疫性疾病患者群体庞大。以中国为例，银屑病患者约650万人，其中中重度患者占30%。而生物制剂因其疗效和安全性优势，正在逐步替代传统疗法。BAT2206若能在中美欧三大市场获批，将显著提升用药可及性，尤其对价格敏感的患者而言，生物类似药的定价通常比原研药低15%-30%，可能成为市场渗透的关键。早在2024年5月，该药物便已在中国提交上市申请并获得受理。此后，百奥泰通过与多家海外企业合作，提前布局商业化网络：美国市场授权给Hikma Pharmaceuticals，巴西由Biomm S.A.负责分销，俄罗斯及独联体国家则交由Pharmapark LLC，降低了市场准入风险，也加速了产品上市后的渗透速度。FDA对生物类似药的审评以严格著称，尤其注重与原研药的“相似性”验证。BAT2206的获批，意味着其药学特性、疗效和安全性已通过FDA的全面评估，与美国市场现有的Stelara®“无临床意义上的差异”。这一认证不仅为百奥泰打开了全球最大药品市场的大门，也为后续欧洲EMA的审评提供了有力背书。  从商业角度看，美国市场的潜力不容小觑。尽管Stelara®的专利已于2023年到期，但强生通过剂型改良和适应症扩展维持了市场优势。而BAT2206凭借价格优势和灵活的剂型组合，包括45mg/0.5mL、90mg/1.0mL皮下制剂及130mg/26mL静脉注射剂，有望在医保控费压力加剧的背景下，快速抢占市场份额。生物类似药“出海”新样本近年来，这家广州药企的“出海”动作频频：阿达木单抗（格乐立®）和托珠单抗（施瑞立®）已在中美欧三地获批；2025年初，其戈利木单抗（BAT2506）更是以最高1.645亿美元的交易额将美国权益授权给印度药企Intas。财报显示，2024年百奥泰营收达7.43亿元，同比增长5.44%，其中海外市场贡献显著。支撑这一战略的，是百奥泰在研发与生产端的持续投入，公司已建立六大技术平台，覆盖抗体筛选、结构设计、ADC（抗体药物偶联物）开发等领域。2024年研发投入高达7.78亿元，占总营收的104.64%。此外，广州永和生产基地的抗体产业园已实现商业化生产，为全球供应提供了产能保障。虽然此次“出海”为国内企业打了样，但生物类似药的“红海”竞争不小。国际市场上，除了原研药Stelara，已有多个生物类似药进入审批或上市阶段。安进、山德士等跨国药企均布局了乌司奴单抗类似药，而百奥泰的竞争优势在于提前通过授权合作锁定区域市场，可借助合作伙伴的本地渠道优势，快速实现商业化，同时降低自身投入风险。在国内市场，华东医药的乌司奴单抗生物类似药“赛乐信”已于2024年10月获批，成为首个国产产品，适应症从成人银屑病扩展至儿童患者，并计划实现全人群覆盖。相比之下，百奥泰的BAT2206在中国尚处于审评阶段，进度稍显滞后。不过，百奥泰通过提前布局海外授权可能以“出口转内销”的策略增强国内市场的品牌影响力。适应症拓展方面，Stelara已获批的适应症包括银屑病、克罗恩病等，而BAT2206若能在临床中验证更广泛的疗效，或通过补充申请扩大适应症范围，将进一步提升市场占有率。不过，这类扩展需投入额外的临床试验资源，且面临同类产品的跟进。另一个不确定因素来自政策环境。FDA对生物类似药的替换政策尚未完全落地，医生和患者的接受度仍需时间培养。此外，百奥是否能扛得住盈利压力？高额研发投入与商业化成本能否在短期内平衡？这些都将是问题。百奥泰的案例为国内生物药企提供了三点启示：其一，差异化布局。选择原研药市场容量大、专利刚到期或即将到期的靶点，可最大化生物类似药的商业价值。其二，合作共赢。通过授权合作，既能分摊风险，又能借助本土企业的渠道优势。其三，技术筑基。从抗体结构设计到生产工艺优化，只有夯实底层技术，才能通过FDA、EMA的严苛审评。  未来，随着中国创新药质量逐步获得国际认可，类似百奥泰的出海模式或将成为主流，而BAT2206在美销售的表现，也将为后续产品的国际化路径提供重要参考。信息来源：［1］https://vip.stock.finance.sina.com.cn/corp/view/vCB_AllBulletinDetail.php?CompanyCode=80093537&gather=1&id=11137797［2］https://www.gelonghui.com/news/5009532版权声明：本文转自药事纵横，如不希望被转载的媒体或个人可与我们联系，我们将立即删除植根上海、辐射全球,药融圈作为生物医药产业级战略平台,以"让智慧与人脉无界流动"为使命,构建覆盖药物研发、生产、流通、商业化的全产业链赋能体系。通过智能化云服务、精准资源链接、产业智库与生态社群四大核心引擎,打造中国医药价值流动的基础设施。在全球化与数字化双重浪潮下,药融圈正重新定义医药资源的流通范式--这里不仅是信息与人脉的枢纽站,更是催生产业变革的化学反应器。我们以中国为原点,编织全球医药智慧网络,让每一次精准链接都成为企业跨越式增长的催化剂。点点赞点分享点推荐