Ustekinumab

REYKJAVIK, Iceland and PARSIPPANY, N.J., Feb. 18, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept), a biologic used to treat eye disorders, including diseases which can lead to vision loss or blindness. The process to obtain regulatory approval is anticipated to be completed in the fourth quarter of 2025. "We are extremely pleased with this new step in the development of our biosimilar candidate to Eylea®, as better access will benefit patients and their caregivers," said Joseph McClellan, Chief Scientific Officer of Alvotech. "Our success in developing multiple biosimilar candidates in parallel for global markets, demonstrates the advantage of our fully integrated approach and broad in-house capabilities in both R&D and manufacturing." “We are delighted to share this latest biosimilar milestone with Alvotech for those living with retinal diseases,” said Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva. “This acceptance continues to build on our shared commitment to improving patient outcomes by offering cost saving and accessible options.” In addition to AVT06, which is a biosimilar candidate for Eylea® (aflibercept) 2 mg, Alvotech is currently also developing AVT29, a biosimilar candidate for Eylea® HD (aflibercept) 8 mg. Teva also holds commercialization rights for AVT29 in the U.S. Eylea® is a widely used biologic for the treatment of eye disorders, such as neovascular (wet) Age-related Macular Degeneration (AMD), macular edema, and diabetic retinopathy. In 2024, sales of Eylea® (low dose and HD combined) in the U.S. were $4.77 billion.1 In January 2024, Alvotech announced positive top-line results from a confirmatory clinical study (AVT06-GL-C01) comparing the efficacy, safety, and immunogenicity of AVT06 with Eylea® in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating therapeutic equivalence and comparable safety including immunogenicity between AVT06 and Eylea®. About AVT06/AVT29 (aflibercept) AVT06/AVT29 is a recombinant fusion protein and a biosimilar candidate to Eylea® (aflibercept) 2 mg and 8 mg dose, which binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability.2 AVT06/AVT29 are investigational products and have not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. Use of trademarksEylea® is a registered trademark of Regeneron Pharmaceuticals Inc. About AlvotechAlvotech 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. Two biosimilars to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine 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), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), 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 https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release. Please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, X and YouTube. About TevaTeva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader, harnessing its generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 57 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com. Alvotech Forward Looking StatementsCertain 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 operating performance of Alvotech and may include, for example, Alvotech’s expectations regarding its ability to complete the development and gain marketing authorization for AVT06 or other biosimilar candidates, Alvotech’s competitive advantages, business prospects and opportunities including product launches, pipeline product development, revenue and diversification, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, and market launches. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential”, “aim” 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 develop and manufacture biosimilar candidates in Alvotech’s current pipeline and manufacture approved and marketed biosimilars; (2) the ability to maintain stock exchange listing standards; (3) changes in applicable laws or regulations; (4) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (5) Alvotech’s estimates of revenue, expenses and profitability; (6) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (7) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (8) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (9) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (10) 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; (11) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements; (12) Alvotech’s ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (13) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (14) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (15) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, conflicts in Ukraine, the Middle East and other global geopolitical tension, on the Company’s business, financial position, strategy and anticipated milestones and (16) 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. Teva Cautionary Note Regarding Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to commercialize Alvotech’s biosimilar product candidate to Eylea® (aflibercept) under the strategic partnership with Alvotech, once regulatory approval is obtained; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generic medicines; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the sections captioned “Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. Sources1. Regeneron investor presentation: https://investor.regeneron.com/static-files/f5556fde-092a-4792-ae53-161550abd551. Accessed on February 10, 20252. EYLEA® (aflibercept) injection, for intravitreal use [current prescribing information]. Regeneron Pharmaceuticals, Inc. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125387s087lbl.pdf. Accessed on February 10, 2025. CONTACTS FOR THE MEDIA AND INVESTOR RELATIONS Alvotech Investor Relations and Global CommunicationsBenedikt Stefansson, VPalvotech.ir@alvotech.com Teva Teva Media InquiriesTevaCommunicationsNorthAmerica@tevapharm.comTeva Investor Relations InquiresTevaIR@Tevapharm.com

据统计，2024年全球双抗市场规模达到130亿美元，其中中国药企康方生物的卡度尼利和依沃西单抗合计销售额预计超过3亿美元，引领肿瘤免疫双抗潮流。 而近日，康方生物再次将双抗应用拓展到了另一个爆款领域——自免领域。 康方生物宣布，其全球首创非肿瘤双特异性抗体IL-4Rα/ST2（AK139）IND获受理，剑指呼吸和皮肤自免疾病大市场。 1 挑战千亿市场 自身免疫性疾病是指机体免疫系统功能异常导致机体攻击自身组织的疾病。目前已知有100种不同类型的自身免疫性疾病，影响全球约7.6%～9.4%的人群。其中特应性皮炎、哮喘、COPD、银屑病等多病种发病人数过亿。而且这些疾病大多属于慢性病，患者用药时间长，存在巨大的需求空间。 近年来，随着对疾病的理解，靶向炎症细胞因子、受体和信号分子的大分子生物药发展迅猛，诞生了多款“超级重磅炸弹”，其中2024年销售额超过百亿美元的就有3个：DUPIXENT、SKYRIZI、STELARA。全球自免药物市场规模正快速增长，总规模超过千亿美元，已成为仅次于肿瘤的全球第二大药物市场。 全球自免药物市场规模（十亿美元） 图片来源：弗若斯特沙利文 在国内，经过多年积累后，国产自免新药也在2024年迎来了爆发，司普奇拜单抗、赛立奇单抗、夫那奇珠单抗接连获批上市，加入千亿美元市场竞争。 然而，传统生物制剂（如单抗药物）往往仅针对单一靶点（如IL-4Rα、IL-13或JAK通路），但自身免疫性疾病往往涉及复杂的免疫信号网络和多靶点异常。例如，特应性皮炎（AD）患者的免疫异常可能同时涉及IL-4、IL-13等细胞因子，单一靶向治疗无法完全阻断疾病进展。而且部分罕见或复杂自身免疫病还缺乏有效的治疗药物。因此开发下一代免疫治疗药物仍有很大的临床需求。 2 一箭双雕，结合两大黄金靶点 相较于作用于单一炎症通路的单抗药物，而AK139可同时靶向IL-4Rα和ST2，实现对IL-4/IL-13（Th2通路）和IL-33（Th1/Th2平衡调节）的双重阻断。且具有靶点协同效应。临床前研究表明，这种协同效应能更全面地抑制2型炎症反应，尤其适用于哮喘、特应性皮炎等由多通路驱动的慢性疾病。 IL-4Rα通路：IL-4、IL-13（拥有共同的受体IL-4Rα）主要参与2型辅助性T细胞（Th2）细胞介导的免疫反应，其介导的2型炎症通路在多种免疫功能中扮演着关键角色，尤其是在过敏性疾病如哮喘、过敏性鼻炎中起着核心作用。 其中再生元和赛诺菲联合开发的DUPIXENT（度普利尤单抗）就是靶向此靶点的融合蛋白，该药已获批适应症涵盖特应性皮炎（AD）、哮喘、慢性鼻窦炎伴鼻息肉病（CRSwNP）、嗜酸性食管炎（EoE）、结节性痒疹（PN）等多个皮肤和呼吸系统适应症，还在2024年获批成为首个治疗慢性阻塞性肺病（COPD）的生物制剂。2024年，该药销售额达到141.5亿美元，成功登顶自免领域新“药王”。 此前康方生物也已开发了IL-4Rα单抗AK120，目前已进入Ⅱ/Ⅲ期临床。AK139作为康方生物非肿瘤领域的首款双抗药物，其中一个靶点也选择了IL-4Rα这一黄金靶点，能够高度特异性结合IL-4Rα，并阻断IL-4Rα与IL-4和IL-13结合及其介导的下游信号通路，同时靶向ST2通路，有望覆盖比“药王”更多的患者。 IL-33/ST2通路：白介素-33（IL-33）作为预警素，可与其特异性受体ST2结合，激活下游信号通路，导致呼吸心血管、肌肉骨骼等多系统炎症性疾病，在2型及非2型炎症中均起关键作用。研究表明，IL-33与其特异性受体ST2在多种自身免疫性疾病异常中表达，例如哮喘、过敏性鼻炎、特应性皮炎等呼吸和皮肤系统疾病。其中罗氏/安进的ST2单抗RG6149已启动针对COPD的Ⅲ期临床研究。 AK139可以特异性结合ST2，抑制IL-33介导的炎症反应。同时，临床前研究显示，AK139具有良好的双特异性抗原结合活性，在抑制炎症因子释放、组织炎症细胞浸润等指标中展现出显著优于IL-4或ST2单靶点抗体的协同效应。 目前全球尚无已上市或处于研发进程中的同时靶向IL-4Rα和IL-33/ST2通路的抗体药物，AK139有望成为呼吸和皮肤系统疾病的突破性疗法，成为下一代自免领域重磅炸弹药物。 3 康方的双抗王国 康方生物以肿瘤免疫双抗而成名，先是推出了全球首款PD-1/CTLA-4双抗卡度尼利单抗上市，又以50亿美金（5亿美金首付款）将PD-1/VEGF双抗依沃西单抗部分权益授权出海。而在去年5月，康方生物又宣布依沃西单抗头对头击败K药（帕博利珠单抗），掀起肿瘤免疫双抗研发热潮。 其HARMONi-2（AK112-303）研究数据表明，依沃西单抗单药对比K药一线治疗PD-L1表达阳性的局部晚期或转移性非小细胞肺癌（NSCLC），显著延长了患者无进展生存期（PFS），风险比（HR）显著优于预期。 凭借这两款双抗，康方生物在2023年首次实现盈利，2024年产品收入有望进一步增长。 而AK139的推进揭示了其进一步的雄心。 依托Tetrabody平台，康方已推动7款双抗进入临床，此前的双抗管线均聚焦在肿瘤领域，而AK139是康方在非肿瘤双抗领域的又一次突破。 图片来源：康方生物 目前，卡度尼利的年销售额已成功跨越十亿元大关，与此同时，依沃西亦顺利获批上市，并在国际舞台上展现出了非凡的风采，有力地构筑了康方在肿瘤双特异性抗体领域的坚固壁垒。而AK139获批临床，标志着康方双抗技术平台向慢性病领域拓展的关键一步，若AK139能够验证其在自身免疫性疾病领域的优势，康方生物在BigBiotech的征程上无疑将迈上一个崭新的台阶，实现更为辉煌的成就。 参考来源： 1.康方生物Akeso：非肿瘤首个双抗|康方生物全球首创IL-4Rα/ST2（AK139）IND获受理，剑指呼吸系统及皮肤疾病领域 2.医药笔记：2024年全球双抗市场规模130亿美元 3.雪球：https://xueqiu.com/6052430783/308779373 4.Glyco-Immunology：看透一个细胞因子：IL-4 声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。 责任编辑 | 小月石 合作、投稿、转载开白 | 马老师 18323856316（同微信）  阅读原文，是受欢迎的文章哦