Guselkumab

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.

5月23日，百奥泰生物制药股份有限公司宣布，其乌司奴单抗生物类似药BAT2206正式获得美国FDA批准，商品名为STARJEMZA，用于治疗成人和儿童中重度斑块状银屑病、活动性银屑病关节炎、克罗恩病以及溃疡性结肠炎。这是中国生物类似药出海的重要突破。生物类似药“出海”，从来不只是“拿批文”那么简单。BAT2206背后的路径、格局和博弈，才是真正值得关注的焦点。Stelara®不会轻易退位：强生的多重防线Stelara®由强生于2009年推出，是靶向IL-12/23通路的生物制剂，累计获批用于斑块状银屑病、银屑病关节炎、克罗恩病、溃疡性结肠炎等多个适应症。2023年，Stelara全球销售额高达108.58亿美元，2024年销售额有所下滑，约为103.61亿美元，但这一“超百亿”市场依然极具价值。随着2023年专利到期，这一“超百亿”市场迎来开放，但强生通过多重防线巩固地位。1. 控制生物类似药节奏：与安进等公司达成和解，延迟生物类似药上市时间，控制竞争节奏。2. 适应症扩展与产品优化：推进克罗恩病一线治疗研究，并通过新一代药物Tremfya构建产品矩阵；原研药在中国扩展至儿童银屑病等适应症。3. 市场与渠道优势：美国医保体系未强制生物类似药替代，且医生处方习惯、PBM（药品福利管理机构）合同可能延缓原研药份额流失，但生物类似药的成本优势或逐步改变格局。BAT2206全适应症突围：拿下批文只是起点百奥泰的乌司奴单抗生物类似药BAT2206（STARJEMZA®）虽已获得FDA批准，但商业化之路仍充满挑战。BAT2206将由Hikma Pharmaceuticals在美国独家推广，但前方障碍不小，包括PBM准入、医生教育、患者认知等多重壁垒。临床上，BAT2206在中重度斑块状银屑病人群中的Ⅲ期试验结果显示，其PASI 75达标率等效于原研药Stelara®，且免疫原性无显著差异，最终获FDA认可为高度相似的生物类似药。然而在美国市场，BAT2206所面临的并非空白赛道。截至目前，已有多款Stelara类似药获得批准，市场格局初步成型。原研药Stelara的45mg规格在美定价高达19212美元/支，而Celltrion公开表示，其类似药上市后将以约3000美元定价，折扣接近1.5折。类似的“深折扣”几乎已成为美国生物类似药的常规打法。百奥泰若想突围，不仅要在定价策略上拿出诚意，还需借力合作方长期的渠道与市场积累，在这片竞争激烈的“超百亿”市场中争取一席之地。出口转内销的“迂回路径”：慢，但有章法目前BAT2206在中国尚处审评阶段，进度上不如华东医药的“赛乐信”（2023年已上市）。但百奥泰并未将中国市场作为首要突破口，而是选择先拿下美国，向全球证明其质量与合规能力。在此基础上，BAT2206已与Gedeon Richter（欧盟）、Tabuk（中东）、Biomm（巴西）、Dr. Reddy’s（东南亚与哥伦比亚）等合作，布局覆盖欧美+新兴市场，通过“全球背书”提升未来在中国医保谈判中的定价与认可度。当然，这种“出口转内销”策略也面临挑战——一方面海外定价高企，可能成为未来医保谈判的心理锚点；另一方面国内患者对“国际背书”的接受度存在不确定性，是否愿意为其支付溢价，还需要市场验证。谁能接住Stelara的“权杖”？随着Stelara®专利壁垒的松动，全球市场正步入“原研延寿、海外替代、国产突围”三方混战的新阶段。强生通过授权合作与产品升级，力图稳固其核心市场份额；与此同时，安进、三星、百奥泰等在欧美市场加快推进生物类似药的替代攻势；在中国，华东医药的“赛乐信”率先上市，百奥泰、石药集团等紧随其后，竞争迅速升温。未来谁能胜出，不在于谁先上市，而在于谁能以国际质量和成本优势打通PBM、医生、患者渠道，构建适应症覆盖、商业执行和医保议价的闭环能力，决战市场主导权。结语：替代只是开始，系统力才是终局战BAT2206的意义，不只是成为中国首个在美获批Stelara全适应症替代药，更在于它代表着中国生物药企是否有能力打通“全球注册—区域合作—价格管理—本土落地”的全链条系统。未来十年，生物类似药市场不会是“劣币驱逐良币”，而是“系统力决定天花板”。百奥泰的出海首枪虽然打响了，但真正的市场争夺战，才刚刚开始。免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部。联系我们ICNS 2025展位火热预定中！扫码立即咨询电话：13816031174（同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多！