Adalimumab biosimilar (Merck Serono Sa)

老药王修美乐已经从制药领域的宝座上退位，然而它在面对生物类似药的冲击时却表现得坚如磐石，其市场地位依然岿然不动。虽然销售量因为更高的回扣而大幅缩水，但处方量份额仍然高居不下。这种现象引发了行业内对于生物类似药法规策略的广泛讨论。首款修美乐生物类似药，Amgen的Amjevita (adalimumab-atto) 上市已经过去了一年多的时间了（2023年1月31日上市），之后又有九款类似物出现在了美国市场，它们针对的都是包括类风湿性关节炎、克罗恩病等自免疫疾病。5月2日，FDA最新批准了勃林格殷格翰公司的 Cyltezo的高浓度、无柠檬酸盐版本，它是修美乐的可互换生物类似药。本来，行业对于修美乐生物类似药上市之后市场占有率变化是相当期待的。但一年过去，这些生物类似药的市场占有率令人沮丧。通过生物类似药降低这些疾病治疗成本的愿景远未实现。从根源上来讲，政策制定者尚未采取必要行动来确保患者能够获得这些低成本产品。如果他们继续这种不作为的姿态，美国医疗保健系统可能会损失高达 1330 亿美元的成本，而且很多患者将无法获得所需的药物。Part.1无视类似药上市，修美乐价格不断攀升修美乐对于美国医疗保健体系的问题在于它的高价格和广泛患者群体，因此这款影响力巨大的药物才能收获历史超过2000亿美元的收入，但其对于医保体系的成本威胁也是不言而喻的。自从2003年上市以来，修美乐的价格每年都在攀升。2013年，每支40 mg 剂量的修美乐注射剂的价格已经从刚推出时的522美元上涨到了1024美元（图1）。就在首款生物类似药上市的2023年，艾伯维仍然选择对修美乐进行提价，达到了每针4000美元。从其生命周期管理来看，修美乐价格已经整体上涨了570.1%，达到如今每年84000-96000美元的水准。图1. 40 mg剂量修美乐注射器价格走势图。（图片来源：AbbVie）Part.2修美乐生物类似药2023年营销惨淡然而医疗保健系统对于打破修美乐“独乐乐”的愿景并没有随着生物类似药的登场而实现。根据生物类似药论坛（Biosimilar Forum）收集的修美乐生物类似药使用数据，2023 年，在 42000 名潜在的联邦政府保险计划Medicare的受益患者中，只有不到1000人接受了成本较低的 Humira生物类似药。生物类似药制造商 Samsung Bioepis 的另一份报告发现，尽管 9 种修美乐生物类似药的标价比修美乐低 85%，但它们在美国市场的占有份额甚至不到 2%（图2）。考虑到它们本可能带来的巨大成本节约，对这些药物的“束之高阁”使得医疗保险受益者和纳税人一年内损失30亿美元。在修美乐生物类似药中，Hadlima和Yusimry 提供的很低的WAC（Wholesale  Acquisition Cost，批发收购成本），比 Humira 低约 85-86%；Idacio 和 Yuflyma 的WAC 较高，仅比 Humira 低约 5-6%；Cyltezo、Amjevita、Hyrimoz、Abrilada 和 Hulio 提供双重定价选项，包括低 WAC 和高 WAC（图3）。 图2. 修美乐及其生物类似药2023年下半年市场占有份额走势图。（图片来源：Samsung Bioepis）图3. 修美乐生物类似药WAC价格图。（来源：Samsung Bioepis）根据美国联邦政府监察长办公室（Office of the Inspector General）的说法，如果患者可以使用修美乐和Enbrel（etanercept，另一种治疗自身免疫性疾病的药物）的生物类似药，并将其放在处方集的首选位置的话，那么联邦政府的Medicare计划每年可以节省数千万美元。但至少在2023年，这样的愿望没有得以实现。值得注意的是，修美乐生物药的市场占有率在PBM政策杠杆的影响下出现了抬头的趋势。BI的Cyltezo 的高浓度、无柠檬酸盐配方获得批准之际，生物类似药占据了更多的修美乐品牌药市场。本月早些时候，领先的药品福利管理公司 CVS Caremark 将修美乐从其主要的全国商业处方中剔除后，生物仿制药的处方量激增 36%。但需要注意的是，修美乐类似药抬头的背后是PBM开始垂直整合的策略。Sandoz 的生物仿制药 Hyrimoz (adalimumab-adaz) 由 CVS Health 子公司 Cordavis 共同开发和商业化，这一款类似药就占据了修美乐类似药增长的 93% 以上。其它类似药的占有率变化仍然有待观察。Part.3 美国与欧洲对修美乐生物类似药覆盖的 巨大差异美国相对较低的市场吸纳率与整个欧洲的情况形成鲜明对比。欧洲的修美乐生物类似药已经上市五年多了（美国的专利丛林导致了修美乐生物类似药在美国延迟上市）。欧洲付款人的购买行为总是倾向于价格较低的治疗替代品，这从逻辑上来说是合理的。例如在部署卫生技术评估时，英国国家健康与护理卓越研究所（NICE）等机构建议医疗保健提供者，在同等有效的替代方案之间选择成本最低的治疗方法。欧洲和英国采购生物类似药的招标系统有助于提高生物类似药的吸收率。投标报价总是遵循正式程序，医院或医疗保健系统的招标过程，需要考虑替代方案在控制药品支出方面的贡献，因此物美价廉的生物类似药总能获得青睐。纵观整个欧洲，报销机构都强烈支持修美乐生物类似药，在许多司法管辖区获得了超过80% 的整体市场份额。而且很多监管机构都没有美国的“可互换性”指定，也促进了生物类似药处方量的增加。欧洲药品管理局许可的生物类似药数量是美国的两倍多（总共 93 种，截止2023年12月初），并且在大多数已批准生物类似药能够迅速占领市场。反观美国，生物类似药委员会（Biosimilars Council）进行的一项新分析发现，美国最大的五个提供Medicare Part D计划的保险公司（United Healthcare、Humana、CVS、Centene 和 Cigna）对于修美乐生物类似药的覆盖仅有6%，而对修美乐“本乐”的覆盖率达到99%（图4）。图4. 美国五大Medicare Part D健康保险机构对修美乐和修美乐生物类似药覆盖程度对比图。（来源：Biosimilars Council）Part.4修美乐“独乐乐”的根源从根源上讲，生物类似药无法与修美乐“同乐乐”的症结，并不在于这些类似药的安全性和有效性，也不在于它们是否带有“可互换性”（interchangeable）标签。问题出现在它们能否被PBM（药品福利管理者）纳入他们的“处方集”之中。这个处方集就是PBM之所以能够在60多年间，以一个不嫁不穑的角色在美国医疗系统中呼风唤雨、左拥右抱的关键。作为美国医疗健康系统中独特存在的“中间人”，PBM在上世纪60年代成立时的宗旨就是帮助单独的雇主保险机构进行行政方面的管理。PBM的产生源于对医疗保健系统中药品成本的管理和控制的需求。随着时间的推移，药品费用逐渐成为医疗支出中的重要部分。医疗保险公司、雇主和政府计划等支付者需要一种方式来管理和降低药品费用，以确保医疗保健系统的可负担性，并为受益人提供质量和经济效益。PBM 作为第三方管理者填补了这一需求的空白，通过谈判、合同管理、药品定价和利润管理等手段，协助支付者有效地管理药品成本，同时保障受益人的用药需求。因此，PBM 的产生是为了在医疗保健系统中更好地管理药品费用，实现成本控制和效率提升的目标。为什么PBM能够“一伸手就碰到天”？这主要在于他们在整个行业中的地位，尤其是他们制定的处方集（formulary）来决定的。处方集就像是PBM“挟天子以令诸侯”的法器一样。处方集是由 PBM制定的药品清单，用于指导医疗保险计划成员获得哪些药品的福利覆盖。这些药品被认作符合特定的临床标准、成本效益或其他标准，因此可以被医疗保险计划提供者批准并且支付。对于未被列入处方集的药品，医疗保险计划成员可能需要支付更高的费用或者根本不享受保险支付的福利。因此，PBM制定的处方集对于药品的市场准入、销售量、定价折扣和医生处方选择等方面具有重要影响。没有被纳入处方集的药品很难实现高市场吸收率，至少在美国如此。了解了PBM和处方集之后，我们再审视一下修美乐生物类似药被处方集吸纳的情况。从目前来看，Medicare 的D 部分对低成本修美乐生物类似药的吸纳率最低。在已推出的几种生物类似药中，有六种的定价结构具有低成本、低回扣的选择。折扣范围为 5% 至 86%，患者本应该获得这些低成本的选择。但实际情况却并非如此，如果医生开具了这些低价生物类似药，而它们并不被相应保险的处方集覆盖的话，让患者自掏腰包去购买这些相对便宜但仍然要每月500美元左右的生物类似药是非常困难的。因此在知道患者的倾向性的情况下，医生一般也不会开具不被纳入处方集的药物。就目前情况而言，PBM 继续青睐成本较高的品牌修美乐生物制剂，将其置于优先的处方集等级，患者更容易获得，而那些成本较低的生物类似药则设置了重重障碍。一些PBM甚至直接拒绝修美乐生物类似药进入处方集，并且没有解释原因（没有解释，就是解释了）。了解了处方集的重要性，下一步的问题就是，为什么PBM选择无视那些等效低价的修美乐生物类似药。道理也很容易理解，爱恨情仇都绕不开一个“钱”字。PBM 也是企业，它们也追求利润。纳入成本高的药物可以为 PBM 带来更高的回报，因为这些药物通常具有更高的利润率，表现在折扣和回扣的设定上。PBM 通常与药品制造商进行谈判，以获取更有利的定价和折扣条件。成本高的药物通常意味着更高的利润空间，制药公司可能会提供回扣或者折扣给PBM，“鼓励”他们将自己的高价药物纳入其处方集。这种回扣或折扣可能以多种形式出现，例如现金返还、折扣药价、赞助活动等。通过提供这些利益，制药公司可以确保他们的药物在PBM的处方集中占据有利位置，从而增加销售量和利润。PBM作为商业实体，其主要目标是盈利。在面临诸如回扣、折扣等利益的诱惑时，他们可能更倾向于选择高价药物，因为这些药物往往会带来更高的利润。虽然高价药物的成本更高，但如果PBM能够通过折扣或回扣等手段获取更多的利润，他们可能会更愿意选择这些药物。除此之外，一些制药公司可能与PBM签订药物回扣或利润共享协议。PBM可能会获得销售特定药物所带来的额外回报。因此，为了最大化其收益，PBM可能会优先选择这些药物，即使它们价格较高。至于谁最终承担了高价格的压力，是委托它们的国家保险机构或者雇主保险，还是更背后的广大患者和保户，PBM就不需要太多关心。他们当然不会把制药公司给他们的利益完全独吞，而是拿出一部分来“恩泽”他们的雇主，但究竟拿出了多少，就是外界很难获取的信息了。明白了这个道理，就不难理解为什么质量等同但价格更低的生物类似物入不了PBM“法眼”的原因了。生物类似药的低市场吸收率阻碍了自由市场竞争的发挥，但这并不是出于它们质量的问题，而且是立法机构如何支持这些低成本药物进入市场的调控政策出了问题。当处方药，特别是医疗保险处方药，优先考虑高成本、高回扣的产品时，最终遭受影响的是提供医疗保险的机构，包括Medicare和Mediaid这样联邦和州政府背景的保险机构，以及雇主保险，当然还有患者本人。今年第一季度出现的新情况，就是上文提及的PBM垂直整合，PBM从最初的裁判员变成了直接入场的运动员。在PBM的操作下，它们合作的生物类似药必然得到更快的市场占有率增长。尽管市场份额扩大，但PBM在整个流程中只手遮天的能力还是令人忧虑。Part.5“众乐乐”当从立法入手针对生物类似药市场吸收慢的问题，政策制定者明心见义地针对问题的根源，即PBM 的反竞争计划阻止患者获得低成本处方药。政策必须优先考虑患者，确保他们可以获得成本较低的生物类似药。迫使PBM吐出通过高价药物获得的高回扣和折扣利益，是政策制定者应当着重发力的方向。实际上，美国参议院财务委员会已经讨论并通过了立法草案，包含支持生物类似药的条款。该草案建议，从 2026 年开始，Mediacre D 部分计划必须涵盖“高折扣生物类似药”，而这些生物类似药的价格比其参考生物制剂至少低 45%，以此促进使用安全、有效和低成本的生物类似药，并直接降低患者的费用。生物类似药的积极“入市”，需要政策制定者“扶上马，送一程”。应尽快采取政策解决方案，让自由市场竞争成为主宰沉浮的主要力量。Ref.Humira cost savings and tips. Single Care. 05. 08. 2023.Brennan, Z. House committee uncovers how Humira’s price spiked by 470% as AbbVie execs cashed bonuses tied to the hikes. Endpoints News. Biosimilars Forum Supports Senate Finance Committee Legislative Discussion Draft Promoting Biosimilars. Biosimilar Development. 03. 11. 2023.Samsung Bioepis. Biosimilar Market Report. 4th Edition. Q1 2024.Medicare Part D and Beneficiaries Could Realize Significant Spending Reductions With Increased Biosimilar Use. U.S. Department of Health and Human Services. Office of Inspector General. Mar. 2022.Cohen, J. Humira Biosimilars Not Gaining Traction Epitomizes Dysfunctional U.S. System. Forbes. 04. 12. 2023.Humira Biosimilar Landscape: Still Waiting. Biosimilars Council. 30. 01. 2024.Reed, J. M. A year in, the U.S. is still not taking advantage of lower-cost biosimilars for Humira. STAT. 14. 02. 2024.End细胞系产品查询投稿丨商务合作转载丨加交流群往期回顾15月| 20家药企裁员（附名单）218亿美元，ADC又出海! 宜联生物宣布新授权32024 ASCO| 默沙东/科伦TROP2 ADC、信达、礼新CLDN18.2 ADC数据公布

Tyenne® is the first tocilizumab biosimilar by Fresenius Kabi, an operating company of Fresenius SE, with an intravenous and subcutaneous formulation approved by the FDA. The tocilizumab biosimilar provides increased access and an affordable, high-quality, and safe treatment option for U.S. patients. Excellent performance of the (Bio)Pharma business in 2024 so far, also driven by Tyenne® which became the first tocilizumab biosimilar available in Europe in November 2023. The launch of the tocilizumab biosimilar contributes directly to growing Fresenius’ (Bio)Pharma platform, a substantial cornerstone of the #FutureFresenius strategy. BAD HOMBURG, Germany--(BUSINESS WIRE)-- Fresenius, via its operating company Fresenius Kabi, announced today the immediate U.S. availability of Tyenne® (tocilizumab-aazg), a biosimilar of Actemra® (tocilizumab). Tyenne®, for use in the treatment of chronic autoimmune diseases, is available in an intravenous (IV) formulation. This press release features multimedia. View the full release here: Fresenius Kabi announced that Tyenne® (tocilizumab-aazg), a biosimilar of Actemra® (tocilizumab) is now available in the U.S. in an IV presentation. Tyenne tocilizumab-aazg) is for use in the treatment of chronic autoimmune diseases. (Photo: Business Wire) Michael Sen, CEO of Fresenius: “With the launch of Tyenne® in the U.S., we have reached another important milestone in accelerating our strong (Bio)Pharma momentum. Growing this platform is a substantial cornerstone of our #FutureFresenius journey. Overall, we have seen an excellent performance of our (Bio)Pharma business in 2024 so far. We are particularly happy with the good progress of our majority-owned biotechnology company mAbxience and the traction of Tyenne®, the first tocilizumab biosimilar available in Europe since November 2023.” Tyenne® is the first tocilizumab biosimilar with an intravenous and subcutaneous formulation approved by the FDA. The biosimilar received FDA approval on March 5, 2024. Tyenne® is Fresenius’ third approved biosimilar available in the U.S. and the second within its immunology portfolio. The biologic medicine is indicated for the treatment of several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. Pierluigi Antonelli, CEO of Fresenius Kabi: “Tyenne® will impact the treatment landscape for inflammatory and immune diseases in the U.S. Reaching ever more patients with our state-of-the-art biopharma portfolio signals a clear growth path in a highly promising market segment. We will continue to roll out our comprehensive pipeline of autoimmune and oncology biosimilars with several molecules in late-stage development.” Supported by Fresenius Kabi’s support program for health care professionals and patients, the company’s biologic medicine provides wider access to more treatment options and contributes to the viability of health care systems. Next to its two available biosimilars, Idacio® (adalimumab) and Stimufend® (pegfilgrastim), Fresenius Kabi has a growing pipeline of autoimmune and oncology biosimilars with several molecules in late-stage development. To learn more about how Fresenius Kabi provides comprehensive patient support for Tyenne® in the U.S. please click here. With #FutureFresenius, Fresenius successfully set the course last year to become a leading therapy-focused company. In line with the strategy, Fresenius has simplified its structure, is sharpening its focus by concentrating on its operating companies Fresenius Kabi and Fresenius Helios and is continuously enhancing its performance. About Tyenne®, a Tocilizumab Biosimilar Tyenne® (tocilizumab-aazg), a biosimilar to Actemra® (tocilizumab), is a prescription medicine called an Interleukin-6 (IL-6) receptor antagonist. It was developed by Fresenius Kabi using advanced analytical and manufacturing technologies for use in the treatment of several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections have occurred in patients receiving the product. Tyenne is contraindicated in patients with known hypersensitivity to tocilizumab products. For more information about Tyenne, please see the full prescribing information for the U.S. here. IMPORTANT SAFETY INFORMATION RISK OF SERIOUS INFECTIONS Patients treated with TYENNE® (tocilizumab-aazg) are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt TYENNE until the infection is controlled. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before TYENNE use and during therapy. Treatment for latent infection should be initiated prior to TYENNE use. Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral and other infections due to opportunistic pathogens. The risks and benefits of treatment with TYENNE should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with TYENNE, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. CONTRAINDICATION TYENNE is contraindicated in patients with known hypersensitivity to tocilizumab products. WARNINGS AND PRECAUTIONS Gastrointestinal Perforations Events of gastrointestinal (GI) perforation have been reported in clinical trials, primarily as complications of diverticulitis in patients treated with tocilizumab. Use TYENNE with caution in patients who may be at increased risk for GI perforation. Promptly evaluate patients presenting with new-onset abdominal symptoms for early identification of GI perforation. Hepatotoxicity Serious cases of hepatic injury have been observed in patients taking intravenous or subcutaneous tocilizumab products. Some of these cases have resulted in liver transplant or death. Time to onset for cases ranged from months to years after treatment initiation. Most cases presented with marked elevations of transaminases (> 5 times ULN), and some cases presented with signs or symptoms of liver dysfunction and only mildly elevated transaminases. Treatment with tocilizumab was associated with a higher incidence of transaminase elevations; increased frequency and magnitude of these elevations were observed when tocilizumab was used in combination with potentially hepatotoxic drugs (e.g., methotrexate). It is not recommended to initiate TYENNE treatment in RA, GCA, PJIA, and SJIA patients with elevated transaminases ALT or AST greater than 1.5x ULN. In patients who develop elevated ALT or AST greater than 5x ULN discontinue TYENNE. Measure liver tests promptly in patients who report symptoms that may indicate liver injury. If the patient is found to have abnormal liver tests, TYENNE treatment should be interrupted. TYENNE should only be restarted in patients with another explanation for the liver test abnormalities after normalization of the liver tests. Laboratory Parameters Laboratory monitoring is recommended due to potential consequences of treatment-related laboratory abnormalities in neutrophils, platelets, lipids, and liver function tests. Dosage modifications may be required. Neutropenia: Treatment with tocilizumab products was associated with a higher incidence of neutropenia. It is not recommended to initiate TYENNE treatment in RA, GCA, PJIA, and SJIA patients with a low neutrophil count i.e., absolute neutrophil count (ANC) less than 2000 per mm3. In patients who develop an ANC less than 500 per mm3 treatment is not recommended. Thrombocytopenia: Treatment with tocilizumab products was associated with a reduction in platelet counts. It is not recommended to initiate TYENNE in RA, GCA, PJIA, and SJIA patients with a platelet count below 100,000 per mm3. In patients who develop a platelet count less than 50,000 per mm3, treatment is not recommended. Elevated Liver Enzymes: It is not recommended to initiate TYENNE treatment in patients with elevated transaminases ALT or AST >1.5x ULN. In patients who develop elevated ALT or AST >5x ULN, treatment is not recommended. Lipid Abnormalities: Treatment with tocilizumab products was associated with increases in lipid parameters such as total cholesterol, triglycerides, LDL cholesterols, and/or HDL cholesterol. Immunosuppression The impact of treatment with tocilizumab products on the development of malignancies is not known, but malignancies were observed in clinical studies with tocilizumab. TYENNE is an immunosuppressant, and treatment with immunosuppressants may result in an increased risk of malignancies. Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, have been reported in association with tocilizumab products and anaphylactic events with a fatal outcome have been reported with intravenous infusion of tocilizumab products. TYENNE for intravenous use should only be infused by a healthcare professional with appropriate medical support to manage anaphylaxis. For TYENNE subcutaneous injection, advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction. If anaphylaxis or other hypersensitivity reaction occurs, stop administration of TYENNE immediately and discontinue TYENNE permanently. Do not administer TYENNE to patients with known hypersensitivity to tocilizumab products. Demyelinating Disorders The impact of treatment with tocilizumab products on demyelinating disorders is not known, but multiple sclerosis and chronic inflammatory demyelinating polyneuropathy were reported rarely in clinical studies. Monitor patients for signs and symptoms of demyelinating disorders. Prescribers should exercise caution in considering the use of TYENNE in patients with preexisting or recent onset demyelinating disorders. Active Hepatic Disease and Hepatic Impairment Treatment with TYENNE is not recommended in patients with active hepatic disease or hepatic impairment. Vaccinations Avoid use of live vaccines concurrently with TYENNE. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving TYENNE or on the effectiveness of vaccination in patients receiving TYENNE. Patients should be brought up to date on all recommended vaccinations prior to initiation of TYENNE therapy, if possible. ADVERSE REACTIONS Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions. DRUG INTERACTIONS In GCA patients, no effect of concomitant corticosteroid on tocilizumab exposure was observed. Cytochrome P450s in the liver are down-regulated by infection and inflammation stimuli including cytokines such as IL-6. Inhibition of IL-6 signaling in RA patients treated with tocilizumab products may restore CYP450 activities to higher levels than those in the absence of tocilizumab products leading to increased metabolism of drugs that are CYP450 substrates. Exercise caution when coadministering TYENNE with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, e.g., oral contraceptives, lovastatin, atorvastatin, etc. USE IN PREGNANCY The limited available data with tocilizumab products in pregnant women are not sufficient to determine whether there is a drug-associated risk for major birth defects and miscarriage. You may report side effects to the FDA at (800) FDA-1088 or . You may also report side effects to Fresenius Kabi at (800) 551-7176. Please see additional Important Safety Information in full Prescribing Information, including Boxed Warning. INDICATIONS TYENNE is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). TYENNE is indicated for the treatment of giant cell arteritis (GCA) in adult patients. TYENNE is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older. TYENNE is indicated for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older. Tyenne® demonstrates Fresenius Kabi’s commitment to providing access to affordable and cost-effective biosimilars to more patients living with autoimmune diseases around the world while enabling savings for health care systems. KabiCare, Fresenius Kabi’s comprehensive patient support program, will be available to patients and health care providers in the U.S. from launch. About Fresenius SE Fresenius SE & Co. KGaA (Frankfurt/Xetra: FRE) is a global healthcare company headquartered in Bad Homburg v. d. Höhe, Germany. In the 2023 fiscal year, Fresenius generated €22.3 billion in annual revenue with its more than 190,000 employees. Fresenius offers solutions to the social challenges posed by a growing and ageing population and the resulting need for affordable, high-quality healthcare. The Fresenius Group comprises the operating companies Fresenius Kabi and Fresenius Helios as well as the investment companies Fresenius Vamed and Fresenius Medical Care. With 140 hospitals and countless outpatient facilities, Fresenius Helios is the leading private hospital operator in Germany and Spain, treating around 26 million patients every year. Fresenius Kabi’s product portfolio includes a range of highly complex biopharmaceuticals, clinical nutrition, medical technology, and generic intravenous drugs. Fresenius was established in 1912 by the Frankfurt pharmacist Dr. Eduard Fresenius. After his death, Else Kröner took over management of the company in 1952. She laid the foundations for a global enterprise that today pursues the goal of improving people’s health. The largest shareholder is the non-profit Else Kröner-Fresenius Foundation, which is dedicated to advancing medical research and supporting humanitarian projects. For more information visit the company website at . Follow us on social media: . About Fresenius Kabi Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients. Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face. Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders. Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group. Tyenne® is a registered trademark of Fresenius Kabi Deutschland GmbH. Idacio® and Stimufend® are registered trademarks of Fresenius Kabi Deutschland GmbH in selected countries. View source version on businesswire.com: Contacts Matt Kuhn (847) 220-3033 matt.kuhn@fresenius-kabi.com Source: Fresenius Kabi Smart Multimedia Gallery Photo Fresenius Kabi announced that Tyenne® (tocilizumab-aazg), a biosimilar of Actemra® (tocilizumab) is now available in the U.S. in an IV presentation. Tyenne tocilizumab-aazg) is for use in the treatment of chronic autoimmune diseases. (Photo: Business Wire) Logo View this news release and multimedia online at: