Adalimumab biosimilar(Celltrion)

近日，BioSpace盘点了2024年销售额最高的10大医药产品。这份名单中既有热门品种如诺和诺德的Ozempic，也有几种面临专利悬崖却设法保持了其市场主导地位的产品，如艾伯维的Humira，以下为这10款药物的简要介绍。 01 帕博利珠单抗 药物名称：Keytruda 公司名称：默沙东 2024年销售额：294.8亿美元 同比变化：+18% 默沙东的重磅PD-1抑制剂Keytruda连续第二年位居制药公司最畅销产品榜首。2024年，Keytruda同比增长18%，销售额达到294.8亿美元。 鉴于Keytruda已成为拥有40多种癌症适应症的疗法，包括各种形式的肺癌和妇科癌症等，因此这一销售额并不令人惊讶。2024年9月，FDA批准Keytruda用于胸膜间皮瘤的一线治疗，根据2024年8月的一份IMARC报告，这一市场到2034年的价值可能超过120亿美元。 但Keytruda的关键专利将于2028年到期，这将使其面临生物类似药竞争，进而瓜分销售额。 监管部门对Keytruda的广泛使用以及更广泛的PD-1抑制剂的担忧似乎也越来越严重。2024年9月，FDA咨询小组以压倒性多数投票决定缩小Keytruda以及百时美施贵宝的Opdivo和Yervoy在胃癌和食管癌中的标签，限制它们在PD-1表达水平低的患者中的使用。但FDA尚未发布正式指令。 默沙东正在尽其所能保持Keytruda的市场主导地位。默沙东公司正在准备开发Keytruda的皮下制剂。2024年11月，默沙东宣布了PD-1抗体Keytruda皮下给药制剂关键的3期MK-3475A-D77试验的阳性顶线结果。如果开发成功，该产品的推出有望延续产品生命周期。 02 司美格鲁肽（Ozempic） 药物名称：Ozempic 公司名称：诺和诺德 2024年销售额：169亿美元 同比变化：+26% 广受欢迎的2型糖尿病药物Ozempic是2024年表现最好的药物之一。诺和诺德在其全年业务报告中透露，GLP-1疗法去年的收入超过1200亿丹麦克朗，约合169亿美元。 相对于2023年，Ozempic的销售额增长了26%——并且有望在未来几年看到更大的上升趋势。Ozempic最初于2017年获得批准以改善血糖控制，并于2020年获得额外批准以降低心血管风险，并于2025年1月获得额外批准以降低患慢性肾病的新适应证。 然而，阻碍Ozempic增长的是《通货膨胀削减法案》（IRA）。今年早些时候，美国医疗保险和医疗补助服务中心（CMS）选择了GLP-1药物Ozempic以及Rybelsus（口服司美格鲁肽）进行第二轮药品价格谈判。在过去的一年里，诺和诺德收到了几次电话，要求降低Ozempic的标价。 面对Ozempic价格上限的前景，诺和诺德已要求美国第三巡回上诉法院加快其对IRA的持续投诉的诉讼程序，诺和诺德声称价格谈判侵犯了其宪法权利。然而，这一论点迄今未能说服法官。 03 比克恩丙诺 药物名称：Biktarvy 公司名称：吉利德 2024年销售额：134亿美元 同比变化：+13% 吉利德的抗逆转录病毒药物Biktarvy扩大了HIV市场的规模，该药物在2024年增长了13%，带来了134.2亿美元的销售额，该制药公司将这一增长归因于对该药物的“更高需求”。 Biktarvy目前是吉利德HIV业务的基石。它占据了美国HIV市场50%以上的份额，与Keytruda和Ozempic不同，Biktarvy在不久的将来没有明显的阻力。该药物的关键专利保护将在未来几年保持不变，并将在2033年之前使仿制药竞争对手无法进入市场。同时，Biktarvy也不在美国医保与医助服务中心的第二轮药品谈判名单之列。 04 阿哌沙班 药物名称：Eliquis 公司名称：BMS，辉瑞 2024年销售额：133亿美元 同比变化：+9% 血液稀释剂Eliquis通过百时美施贵宝和辉瑞之间的紧密合作，在2024年实现了133亿美元的收入，销售额同比增长9%。 长期以来，这种药物一直是两家公司的宝贵资产，但这可能很快就会结束。Eliquis将在2026年失去市场独占权——几种仿制药已经排队等候，渴望进入美国市场并蚕食该药物的收益。其中包括来自Mylan Pharmaceuticals和Micro Labs Limited的仿制药产品，FDA于2019年12月初批准了这些产品。 Eliquis也是去年进行CMS药品价格谈判的第一批药物之一，价格为231美元，定于2026年生效，比原始标价低56%。 为了应对Eliquis可能造成的收入损失，BMS启动了一项数十亿美元的节流计划，目标是到2025年底削减15亿美元的成本，到2027年再削减20亿美元的成本。辉瑞正在采取类似的方法，在2024年设定了35亿美元的节流目标，并在2027年底之前再实现减少15亿美元成本的目标。 05 度普利尤单抗 药物名称：Dupixent 公司名称：Sanofi、Regeneron 2024年销售额：130亿美元 同比变化：+23% 赛诺菲和再生元正在联合将免疫学重量级产品Dupixent商业化，特应性皮炎、哮喘该公司去年的收入为130.72亿美元，同比增长23%。 与Biktarvy一样，Dupixent似乎没有与专利和IRA相关的问题。该药物将在2031年之前保持市场独占权。FDA于2024年9月批准Dupixent用于治疗慢性阻塞性肺病，预计将于今年推出。此前，Dupixent已被批准用于特应性皮炎、哮喘。因此，该产品前景光明。 06 利生奇珠单抗 药物名称：Skyrizi 公司名称：艾伯维 2024年销售额：117亿美元 同比变化：+50.9% 艾伯维（AbbVie）抗IL-23疗法Skyrizi，是这份名单上增长最快的资产。Skyrizi的销售额同比增长50.9%，到2024年为公司赚取了117.18亿美元。 修美乐（Humira）多年来一直是世界上最畅销的药物。2024年第三季度，尽管Humira的销售额持续下降，但Skyrizi以及JAK抑制剂Rinvoq的销售额帮助AbbVie以微弱优势超过分析师的预期。这一趋势一直持续到第四季度。 在2月的一份报告中，针对该制药公司的全年业务报告，分析师表示，Skyrizi和Rinvoq将为艾伯维“迎来一个新的增长时代”，艾伯维终于完全摆脱了Humira的依赖。 Skyrizi市场独占性将持续到2031年。 7/8 达雷妥尤单抗&乌司奴单抗 药物名称：Darzalex、Stelara 公司名称：强生 Darzalex 2024年销售额：117亿美元 同比变化：+20% Stelara 2024年销售额：103亿美元 同比变化：-4.6% 强生在2024年有两款最畅销的药物：一款是Darzalex（达雷妥尤单抗），另一款是Stelara（乌司奴单抗）。 Stelara是一种用于各种炎症性疾病的抗IL-12和IL-23抗体，于2023年9月失去了关键专利保护。此后，其生物类似药进入了美国市场，虽然尚未完全取代Stelara，但已经侵蚀了其市场份额。2023年，该生物制剂的收入为108.6亿美元。去年，销售额下降4.6%至103.4亿美元。 为了弥补收入损失，强生公司正在依靠其癌症药物Darzalex，这是一种被批准用于多发性骨髓瘤的抗CD38溶细胞抗体。2024年，Darzalex带来了116.7亿美元的收入，同比增长近20%。根据相关报告，Darzalex将帮助推动强生的癌症治疗药物（包括其CART疗法Carvykti以及双特异性抗体Tecvayli和Talvey）复合年增长率达到15.3%，到2029年销售额达到271亿美元。 强生继续致力于扩大Darzalex的标签，包括2024年9月向FDA提交申请，允许该药物用于不符合干细胞移植条件的新诊断多发性骨髓瘤患者，以及2024年11月提交高危冒烟多发性骨髓瘤申请。Darzalex将保护关键专利保护到2029年。 09 阿达木单抗 药物名称：Humira 公司名称：艾伯维 2024年销售额：90亿美元 同比变化：-37.6% Humira的销售额同比下降37.6%，现在显然已经过了其巅峰时期。2024年，这款曾经占主导地位的抗炎疗法为艾伯维带来了89.93亿美元的收入。 修美乐失宠的罪魁祸首显然是日益激烈的生物类似药竞争。自从该药物在2023年失去关键专利保护以来，一些仿制产品进入市场，包括安进的Amjevita、Celltrion的Yuflyma、Cordavis和Sandoz的Hyrimoz以及勃林格殷格翰的Cyltezo。 修美乐市场侵蚀的另一个主要驱动因素是CVS Caremark（美国最大药品零售商）于2024年4月将该品牌药物从其主要国家处方集中删除，转而支持生物类似药，包括其Cordavis阿达木单抗品牌Hyrimoz。Cordavis是CVS Caremark的子公司，于2023年8月成立。 不过，在2025年第一季度版的三星BioEPIS生物类似药市场动态报告中，Humira仍然是最大的阿达木单抗品牌，控制着72%的市场。在同一报告的2024年第三季度版本中，Humira拥有82%的市场份额。 10 Gardasil 药物名称：Gardasil 公司名称：默沙东 2024年销售额：86亿美元 同比变化：-3% 这份名单上唯一的疫苗——默沙东的人瘤病毒疫苗Gardasil在2024年的销售额下降了3%，共创造了85.8亿美元的收入。 Gardasil关键专利保护将于2028年到期，尽管没有生物类似药的出现，疫苗的前景看起来并不乐观。随着著名的疫苗批评者小罗伯特·肯尼迪（Robert F. Kennedy Jr.）担任卫生与公众服务部长。对默沙东和Gardasil来说，更重要的是关注美国卫生当局将如何处理疫苗的问题。 此外，Gardasil最近在中国被批准用于男性。2月默沙东公司宣布，由于中国疫苗库存居高不下，将暂停向中国运送Gardasil。 参考资料： 1.https://www.biospace.com/business/10-best-selling-drugs-of-2024-rake-in-billions-amid-exclusivity-threats *声明：本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息，并非也不会进行治疗或诊断方案推荐，也不对相关投资构成任何建议。内容如有疏漏，欢迎沟通指出！ 识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！ 请注明：姓名+研究方向！ 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

STEQEYMA ®, one of the first-wave biosimilars to STELARA®, is now available in the U.S. Approved for the same indications as the reference product, STEQEYMA will be priced with a wholesale acquisition cost (WAC) list price at an 85% discount to the current WAC list price of STELARA to help improve patient access to high-quality biologic treatments[1] With the launch of STEQEYMA, Celltrion expands its immunology portfolio beyond tumor necrosis factor (TNF)-alpha inhibitors, to include interleukin (IL)-12 and IL-23 inhibitors, broadening treatment options for multiple immune-mediated diseases Celltrion has nine biosimilars and five immunology biologics granted marketing authorization in the U.S. JERSEY CITY, N.J., March 12, 2025 /PRNewswire/ -- Celltrion today announced the U.S. launch of STEQEYMA ® (ustekinumab-stba), a biosimilar to STELARA ® (ustekinumab), following approval by the U.S. Food and Drug Administration (FDA) in December 2024. STEQEYMA is approved for the same indications as STELARA, providing consistency in treatment for patients and healthcare providers.[1] STEQEYMA is indicated for the treatment of plaque psoriasis (PsO) and psoriatic arthritis (PsA) in adult and pediatric patients, as well as Crohn's disease (CD) and ulcerative colitis (UC) in adult patients. It is available in both subcutaneous injection and intravenous infusion.[1] "Chronic inflammatory diseases such as plaque psoriasis and psoriatic arthritis place significant burden on patients," said Mark G. Lebwohl*, MD, Icahn School of Medicine at Mount Sinai, New York. "Biosimilars increase access to essential therapies, while maintaining the same high standards as the reference product. The availability of STEQEYMA provides patients and healthcare providers a cost-effective alternative to manage chronic inflammatory diseases." STEQEYMA will be priced with a WAC list price at an 85% discount to the current WAC list price of STELARA to help improve patient access to high-quality biologic treatments. The FDA approval of STEQEYMA was based on the totality of evidence, including the results from a Phase III study in adults with moderate to severe plaque psoriasis, in which the primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. The clinical results demonstrated that STEQEYMA and its reference product, ustekinumab, are highly similar, and have no clinically meaningful differences in terms of safety and efficacy. [2],[3] "The introduction of STEQEYMA in the U.S., as one of the first-wave biosimilars to STELARA, marks an important step in our ongoing efforts to expand patient access to high-quality biologic treatments," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "With this launch, we are expanding our immunology portfolio beyond TNF-alpha to include IL-12/23 inhibitors, offering more options for multiple immune-mediated diseases. To further enhance accessibility, Celltrion is actively collaborating with key pharmacy benefit managers to secure broader formulary coverage for STEQEYMA." STEQEYMA is supported by Celltrion's comprehensive patient and practice support programs, designed to assist patients throughout their treatment journey. Celltrion offers a suite of resources, including Celltrion CONNECT® Patient Support Program and Celltrion CARES™ Co-pay Assistance Program, benefits verification, prior authorization assistance, and co-pay assistance. Eligible patients with private or commercial insurance may pay as little as $0 out of pocket per dose. Patients who are uninsured may be eligible to receive STEQEYMA through the Celltrion CONNECT® Patient Assistance Program (PAP). Additionally, nurses will be available to answer patient questions and provide injection support. Visit to learn more. Celltrion has nine biosimilars approved by the FDA, demonstrating its established leadership in the biosimilar development space and its commitment to advancing high-quality treatments. STEQEYMA has also received approval in key global markets, including the European Union, Canada and Australia. Notes to Editors: *Dr. Mark Lebwohl is a paid consultant for Celltrion. About STEQEYMA ® (ustekinumab-stba) STEQEYMA ®, formerly known as CT-P43, is a human IL-12 and -23 antagonist indicated for multiple immune-mediated diseases. It encompasses all indications approved for the STELARA ® reference product, including psoriasis (PsO), psoriatic arthritis (PsA), Crohn's disease (CD), ulcerative colitis (UC) in adults, and PsO and PsA in pediatric patients 6 years of age and older. STEQEYMA is available in both subcutaneous and intravenous formulations. The subcutaneous injection comes in two strengths: 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe. The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial. INDICATIONS STEQEYMA ® (ustekinumab-stba) is indicated for the treatment of: Plaque Psoriasis (PsO) in adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Psoriatic Arthritis (PsA) in adults and pediatric patients 6 years of age and older with active psoriatic arthritis. Crohn's Disease (CD) in adult patients with moderately to severely active Crohn's disease. Ulcerative Colitis (UC) in adult patients with moderately to severely active ulcerative colitis. IMPORTANT SAFETY INFORMATION STEQEYMA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in STEQEYMA. Serious infections have occurred. Avoid starting STEQEYMA during any clinically important active infection. If a serious or clinically significant infection develop, discontinue STEQEYMA until the infection resolves. Serious infections from mycobacteria, salmonella, and BCG vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Consider diagnostic tests for these infections as dictated by clinical circumstances. Evaluate patients for TB prior to starting STEQEYMA. Initiate treatment of latent TB before administering STEQEYMA. Ustekinumab products may increase risk of malignancy. The safety of ustekinumab products in patients with a history of or a known malignancy has not been evaluated. Monitor all patients receiving STEQEYMA for signs of malignancies. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STEQEYMA. If Posterior Reversible Encephalopathy Syndrome (PRES) is suspected, treat promptly, and discontinue STEQEYMA. Avoid use of live vaccines in patients during treatment with STEQEYMA. Non-live vaccinations received during STEQEYMA treatment may not elicit enough immune response to prevent disease. If diagnosis of noninfectious pneumonia is confirmed, discontinue STEQEYMA and institute appropriate treatment. The most common adverse reactions (≥3%) reported in patients receiving ustekinumab were: Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, and fatigue. CD: vomiting, nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. UC: nasopharyngitis, nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea. For more information, see Full Prescribing Information . About Celltrion Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website . and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has nine biosimilars approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), STEQEYMA® (ustekinumab-stba), AVTOZMA® (tocilizumab-anoh), OSENVELT®/ STOBOCLO® (denosumab-bmwo), and OMLYCLO® (omalizumab-igec), as well as a novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit and stay updated with our latest news and events on our social media: LinkedIn. FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares," "hopes to," "upcoming," "plans to," "aims to," "to be launched," "is preparing," "once gained," "could," "with the aim of," "may," "once identified," "will," "working towards," "is due," "become available," "has potential to," the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. Trademarks STELARA® is a registered trademark of Johnson & Johnson. STEQEYMA® is a registered trademark of Celltrion, Inc., used under license. References For further information please contact:  Andria Arena [email protected] +1 516-578-0057 SOURCE Celltrion WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED