Sandoz GmbH

CIMERLI®*, a ranibizumab biosimilar, is interchangeable with LUCENTIS®** (ranibizumab injection) for all approved indications Dedicated retina sales and field reimbursement team integrated into Sandoz, ensuring seamless experience for providers and patients March 4, 2024 – Sandoz, the global leader in generic and biosimilar medicines, has completed the acquisition of the US biosimilar CIMERLI®* (ranibizumab-eqrn) from Coherus BioSciences, Inc, ahead of anticipated timelines. The acquisition builds on the leading Sandoz ophthalmic platform in the US and lays an even stronger foundation for future product launches. Keren Haruvi, President Sandoz North America said: “Today we further expand the Sandoz biosimilar portfolio, while advancing our mission in the US of pioneering patient access to more affordable and much-needed medicines. With the addition of CIMERLI® to our existing ophthalmology franchise, we can now offer even more treatment options for US patients with vision impairment and loss.” CIMERLI® is indicated for the treatment of certain retinal diseases that, if left untreated, can cause vision loss, which ranks among the top 10 causes of disability in the United States.1 It is an anti-VEGF therapy within a class of biologics that helps retinal patients maintain or gain vision.2 Sandoz and Coherus entered into an agreement in January 2024 through which Sandoz agreed to acquire the full CIMERLI® business for an upfront cash purchase price of USD 170 million. The transaction includes a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access to proprietary commercial software. CIMERLI®* solution for injection (6 mg/mL and 10 mg/mL) is an FDA-approved biosimilar to reference product LUCENTIS®** (ranibizumab injection) indicated for the treatment of multiple retinal diseases, including neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularization (mCNV).3 CIMERLI®* is an anti-VEGF therapy within a class of biologics that helps retinal patients maintain or gain vision.2 CIMERLI®* was approved by the FDA in August 2022, having met FDA’s rigorous standards of biosimilarity to the reference product, including safety, efficacy and quality. Launched in October 2022, it is the first and only FDA-approved biosimilar interchangeable with LUCENTIS®** for all indications. References Centers for Disease Control and Preventon. Vision Loss: A Public Health Problem. December 19, 2022. Accessed February 22, 2024. Vision Loss: A Public Health Problem | CDC American Academy of Ophthalmology. Anti-VEGF Treatments. July 26, 2023. Accessed February 22, 2024. Anti-VEGF Treatments - American Academy of Ophthalmology (aao.org). Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. 22,000 people of more than 100 nationalities work together to bring Sandoz medicines to some 500 million patients worldwide, generating substantial global healthcare savings and an even larger total social impact. Its leading portfolio of more than 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to the year 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the first biosimilar in 2006. In 2022, Sandoz achieved sales of USD 9.1 billion and core EBITDA of USD 1.9 billion. The content above comes from the network. if any infringement, please contact us to modify.

转自：蒲公英Ouryao 综合：无忧近日，多个跨国药企宣布人事变动，罗氏、晖致、诺和诺德。大中华区高管也有5位变动。罗氏基因泰克首席执行官离职：11月1日，罗氏集团宣布，旗下基因泰克首席执行官AlexanderHardy已决定离开公司，并于2023年11月1日立即卸任。  AlexanderHardy于2005年加入基因泰克，在2019年3月担任首席执行官之前，曾担任过多个高级管理职位。  罗氏表示，在最近AlexanderHardy休假期间，美国商业组合负责人AshleyMagargee一直担任临时首席执行官，她将继续担任这一职务，直到宣布正式继任者为止。  Magargee于2004年加入基因泰克，此前曾在罗氏和基因泰克担任生命周期管理、数字客户体验和市场准入方面的高级管理职位，还曾担任新加坡总经理。  晖致总裁退休：10月24日，全球仿制药巨头晖致（Viatris）宣布其总裁Rajiv Malik将于2024年4月1日退休，不再担任公司高管。Rajiv Malik在担任晖致总裁之前，他在Mylan公司担任过执行副总裁、全球技术部运营主管、总裁等职，更早之前，他曾在Sandoz GmbH担任全球开发和注册负责人，在Ranbaxy担任全球法规事务和制药研究部主管。诺和诺德副总裁将退休：据“医药代表”10月27日消息，10月23日，诺和诺德全球高级副总裁兼大中国区总裁周霞萍向员工宣布，新兴事业部副总裁高堃决定自2024年1月1日起从诺和诺德退休。  为了准备顺利交接，高堃将继续领导新兴事业部直至12月5日。过渡期间，由张一帆暂时负责新兴事业部。  高堃已在诺和诺德工作24年，从做医药代表起，历任销售经理、区域业务经理、销售总监、区域业务副总裁等职位。2019年1月，高堃被任命为新兴事业部副总裁。  中华区高管变动的还有5位。1、GSK中国特药事业部新任命  根据“医药代表”10月27日消息，10月26日，葛兰素史克(GSK)中国特药业务负责人余锦毅宣布，赵亮将担任特药事业部多渠道客户互动负责人，全面负责特药事业部倍力腾、新可来产品组在目标市场的医保政策落地执行策略。这项任命自自11月1日起生效。  赵亮曾任职于拜耳、杨森制药，2010年加入GSK，现任GSK中国呼吸业务部区域总监。 2、勃林格殷格翰大中华区换帅：10月17日，“勃林格殷格翰中国”官微宣布：MohammedTawil将于2024年1月1日接替董博文(Dr.PavolDobrocky)，担任勃林格殷格翰大中华区（中国大陆、香港及台湾地区）总裁兼首席执行官。  MohammedTawil于1995年加入勃林格殷格翰，成为约旦分公司的医药代表，此后，他曾在近东、中东和北非相继担任重要岗位。2017年，他赴勃林格殷格翰总部担任人药事业部区域业务经理一职，对口中国、墨西哥、巴西和南美市场。2020年起至今，担任勃林格殷格翰IMETA大区（印度、中东、土耳其及非洲）总裁、首席执行官及人用药品事业部负责人。    此前，董博文在今年3月1日正式上任勃林格殷格翰大中华区（中国大陆、香港及台湾地区）总裁兼CEO，距离这次新任命发布仅过7个月。  3、诺和诺德前大中国区副总裁离职：据“药圈大神”10月31日消息，诺和诺德前大中国区副总裁、首席数字官吴晓敏先生已经于10月13日离开该公司并寻求外部机会。吴晓敏自2021年加入诺和诺德，作为大中国区数字化健康部门负责人，带领团队运营多个数字化平台，建立数字化学院，推动多个数字化创新项目启动和执行。4、礼来中国新人事任命：10月1日，礼来中国新人事任命生效——原糖尿病联盟事业部代理负责人苑平被任命为糖尿病portfolio事业部全国执行销售总监，由原肿瘤Portfolio事业部负责人刘爱华接任糖尿病联盟事业部负责人，两人均直接向礼来中国糖尿病事业部副总裁蒋逸飞汇报。5、诺华中国总裁离任：10月1日，诺华的新任命也正式生效，诺华集团中国总裁贝德年正式离任，由诺华创新药物中国总裁张颖在现职之外接任诺华集团中国总裁一职。公开消息显示，张颖于2011年加入诺华，2017年担任诺华制药中国总裁，2022年6月1日起担任诺华创新药物中国总裁。参考：MedTrend医趋势 医药代表 药圈大神 赛博蓝蒲公英新书《FDA警告信回顾与案例解读》预售：

Biosimilar Tyruko® approved for all indications of reference medicine, as first and only biosimilar to treat relapsing forms of multiple sclerosis (MS) in EuropeDecision based on evidence from extensive analytical characterization demonstrating similarity of biosimilar with reference biologic, in addition to Phase I and confirmatory Phase III studies. Sandoz is committed to accelerate access to potentially life-changing treatments, while generating savings for healthcare systems and patients around the world Basel, September 26, 2023 — Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Commission (EC) granted marketing authorization for the first and only biosimilar Tyruko® (natalizumab), developed by Polpharma Biologics. The authorization covers treatment as a single disease-modifying therapy (DMT) in adults with highly active RRMS, the same indication as approved by the EC for the reference medicine Tysabri®* (natalizumab).1 Rebecca Guntern, President Europe, Sandoz, said: “Multiple sclerosis is a chronic condition with no cure at present and timely access to affordable, high-quality healthcare is therefore even more essential. Today’s approval brings us one step closer to reducing the burden of this disease for those living with multiple sclerosis in Europe by making the life-enhancing treatments they need more accessible.” MS is a chronic inflammatory and neurodegenerative disease of the central nervous system that can drastically affect daily life.2 Most people living with MS experience periods of new or worsening of existing symptoms known as relapses followed by periods of disease remission, when the symptoms improve partially or completely.3 Early treatment with DMTs can change the course of a person’s MS and reduce future disability. However, access to DMTs is not universal; 72% of countries cite barriers to accessing DMTs and the cost of MS medicines is a barrier to access in many countries, according to the Atlas of MS Report.4 Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics in 2019. Under this agreement, Polpharma Biologics will maintain responsibilities for development of medicine, manufacturing and supply of drug substance. Through an exclusive global license, Sandoz has the rights to commercialize and distribute it in all markets. The comprehensive regulatory submission package included evidence derived from an extensive analytical and functional characterization, in addition to results from a Phase I PK/PD study and a confirmatory Phase III Antelope study in RRMS patients. Both studies met their primary endpoints, confirming that the biosimilar matches the reference biologic in terms of pharmacokinetics as well as efficacy, safety and immunogenicity. Tyruko® has the same strength/ dosage form, intravenous (IV) route of administration, dosing regimen and presentation as the reference medicine. Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably across a range of areas including immunology, oncology, supportive care, and endocrinology. It has a leading global portfolio with eight marketed biosimilars and a further 25 assets in various stages of development. Since launching the first biosimilar in Europe in 2006, Sandoz has helped to create early and expanded patient access to life-altering medicines while increasing healthcare savings and creating competition that fuels further innovation. About Tyruko® (natalizumab)Tyruko® has been developed to match the reference medicine, an established, highly effective anti-α4 integrin monoclonal antibody used as disease modifying treatment in relapsing forms of multiple sclerosis (MS). Tyruko is indicated in the EU as a single disease-modifying therapy (DMT) in adults with highly active relapsing-remitting multiple sclerosis (RRMS). Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. References European Medicines Agency (EMA). Tysabri EPAR. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/Tysabri [Accessed August 2023]MS International Federation. What is MS? October 2021. Available from: https://www.msif.org/about-ms/what-is-ms/ [Accessed August 2023]Mayo Clinic. About Multiple Sclerosis. 2022. Available from: https://www.mayoclinic.org/diseases-conditions/multiple-sclerosis/symptoms-causes/syc-20350269. [Accessed August 2023]MS International Federation. Atlas of MS 3rd edition: Clinical management of multiple sclerosis around the world. Available from: https://www.msif.org/wp-content/uploads/2021/05/Atlas-3rd-Edition-clinical-management-report-EN-5-5-21.pdf. [Accessed August 2023] * Tysabri® is a registered trademark of Biogen MA, Inc. # # # About SandozSandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines covers all major therapeutic areas. Sandoz on social media:LinkedIn: https://www.linkedin.com/company/sandozTwitter: https://twitter.com/sandoz_globalFacebook: https://www.facebook.com/sandozglobal/Instagram: https://www.instagram.com/sandozglobal CEO Richard Saynor on LinkedIn: https://www.linkedin.com/in/richard-saynor/ # # # Sandoz Global CommunicationsCentral North America Chris Lewis+49 174 244 9501Leslie Pott+1 609 627 5287 Novartis Media RelationsE-mail: media.relations@novartis.com Central North America Richard Jarvis+41 79 584 2326Julie Masow+1 862 579 8456 Switzerland Satoshi Sugimoto +41 79 619 2035 Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com Central North America Samir Shah+41 61 324 7944Sloan Simpson+1 862 345 4440Nicole Zinsli-Somm+41 61 324 3809Parag Mahanti+1 973 876 4912Isabella Zinck+41 61 324 7188