A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Ustekinumab (AVT04) and Stelara® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Safety and Efficacy study of AVT04 (Alvotech Biosimilar to Ustekinumab), in patients with moderate to severe plaque psoriasis

开始日期2021-06-03

申办/合作机构

Alvotech Swiss AG

NCT04744363

/ Completed临床1期

Phase 1, FIH, Randomized, Double-blind, Single-dose, Parallel-group, 3-arm Study Comparing the PK, Safety, Tolerability, and Immunogenicity Profiles of AVT04, EU-approved Stelara®, and US-licensed Stelara® in Healthy Adult Subjects

Protocol Title:
A Phase 1, first-in-human, randomized, double-blind, single-dose, parallel-group, 3-arm study comparing the pharmacokinetic, safety, tolerability, and immunogenicity profiles of AVT04, EU approved Stelara®, and US-licensed Stelara® in healthy adult subjects
Short Title:
A first-in-human randomized, double-blind study to compare AVT04 with EU-approved Stelara and US-licensed Stelara as a single-dose subcutaneous injection in healthy adult subjects
Rationale:
Alvotech (hereafter, the Sponsor) is developing AVT04 globally as a proposed biosimilar to the reference product Stelara (ustekinumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT04. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT04 and the reference products EU approved Stelara and US-licensed Stelara, in addition to evaluating the safety and tolerability of AVT04, when administered as a single 45 mg/0.5 mL SC dose.

开始日期2021-05-25

申办/合作机构

Alvotech Swiss AG

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100 项与乌司奴单抗生物类似药（Alvotech）相关的临床结果

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100 项与乌司奴单抗生物类似药（Alvotech）相关的转化医学

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100 项与乌司奴单抗生物类似药（Alvotech）相关的专利（医药）

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项与乌司奴单抗生物类似药（Alvotech）相关的文献（医药）

2026-06-01·NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY

Efficacy and safety of ustekinumab biosimilars for treating moderate-to-severe plaque psoriasis: a systematic review and network meta-analysis

Review

作者: Jia, Luyao ; Li, Zhenhua ; Liu, Chenyu ; Tang, Xin ; Ye, Yingying

To compare the efficacy and safety of different ustekinumab biosimilars for treating moderate-to-severe plaque psoriasis (PP), providing an evidence-based basis for clinical medication. We systematically searched randomized controlled trials on ustekinumab biosimilars for treating moderate-to-severe PP in adults from Embase, PubMed, Cochrane Library, and Web of Science. Stata 18.0 was utilized for data analysis. Nine studies were included, involving 4293 moderate-to-severe PP patients. 1) Ustekinumab biosimilars and the reference listed drug (RLD) ustekinumab-RP had no significant difference in the psoriasis area and severity index (PASI) improvement (P > 0.05), and the biosimilar CT-P43 was most effective in improving PASI at different time points. 2) For the dermatology life quality index, Bmab1200, AVT04 and CT-P43, had statistically significant differences from the RLD (P < 0.05). 3) The biosimilar CT-P43 was most effective in improving the Physician Global Assessment score, with the highest SUCRA value (99.8%). 4) The reduction of the body surface area and the treatment-emergent adverse event rate had no statistically significant difference from the RLD (P > 0.05). 5) The biosimilar CT-P43 and Bmab1200 demonstrated a lower probability of generating anti-drug antibodies, showing statistically significant differences from other biosimilars (P < 0.05). Ustekinumab biosimilars demonstrate comparable efficacy and safety to ustekinumab-RP for treating moderate-to-severe PP in adults. The biosimilar CT-P43 is more effective in improving short-term PASI. Due to limitations in the number and quality of included studies, more high-quality studies are required to validate these findings.

2024-07-01·Clinical Drug Investigation

AVT04: An Ustekinumab Biosimilar

Review

作者: Blair, Hannah A

AVT04 (Uzpruvo^®) is a biosimilar of the reference anti-interleukin (IL)-12 and IL-23 monoclonal antibody ustekinumab. It is approved in the EU for plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis and Crohn's disease as per the reference product. AVT04 has similar physicochemical characteristics to those of reference ustekinumab, and the pharmacokinetic similarity of the agents has been shown in healthy volunteers and patients with moderate to severe chronic plaque psoriasis. AVT04 demonstrated clinical efficacy similar to that of reference ustekinumab in patients with moderate to severe chronic plaque psoriasis, and was generally well tolerated in this population. The tolerability, safety and immunogenicity profiles of AVT04 were similar to those of reference ustekinumab, and switching from reference ustekinumab to AVT04 had no impact on efficacy, safety or immunogenicity. The role of reference ustekinumab in the management of inflammatory diseases is well established and AVT04 provides an effective biosimilar alternative for patients requiring ustekinumab therapy.

2023-08-03·Expert opinion on biological therapy

Randomized, double-blind, multicenter study to evaluate efficacy, safety, tolerability, and immunogenicity between AVT04 and the reference product ustekinumab in patients with moderate-to-severe chronic plaque psoriasis

Article

作者: Berti, Fausto ; Otto, Hendrik ; Stroissnig, Heimo ; Feldman, Steven R ; Haliduola, Halimu N ; Duijzings, Paul ; Leutz, Steffen ; Ruffieux, Ruth ; Reznichenko, Nataliya

BACKGROUND:

This study compared efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity between AVT04 and reference product (RP) ustekinumab (Stelara®) in patients with moderate-to-severe chronic plaque psoriasis (PsO).

PATIENTS AND METHODS:

This multicenter, double-blind, 52-week study randomized patients in 1:2 ratio to AVT04 or RP. At week 16, responsive patients (≥50% improvement in psoriasis area and severity index (PASI)) previously on AVT04 continued on AVT04, while those on RP were re-randomized 1:1 to switch to AVT04 or stay on RP. The primary endpoint was a percent improvement in PASI from baseline to week 12. Therapeutic equivalence was demonstrated if the confidence interval (CI) for the adjusted difference in means was contained within the equivalence margins; ±10% (90%CI).

RESULTS:

Of the 581 patients initially randomized (AVT04:RP, 194:387), 575 completed week 16 and 544 completed end of study visit. The percent PASI improvement for AVT04 vs RP was 87.3% vs 86.8% (CI: -2.14%, 3.01%); study met its primary endpoint. Efficacy, safety and PK profiles were comparable across treatment arms throughout the entire study duration, and the incidence of antibodies to ustekinumab had no clinically meaningful impact.

CONCLUSION:

This study demonstrates the therapeutic equivalence between AVT04 and RP in patients with moderate-to-severe chronic PsO, with similar safety and tolerability.

TRIAL REGISTRATION:

NCT04930042; EudraCT Number: 2020-004,493-22.

184

项与乌司奴单抗生物类似药（Alvotech）相关的新闻（医药）

2026-10-07

·BioSpace

Alvotech and LOTTE Biologics announce US-based manufacturing agreement to increase global supply

Alvotech and LOTTE Biologics signing ceremony Alvotech and LOTTE Biologics signing ceremony to commemorate the formation of a strategic manufacturing agreement on October 6, 2026 Collaboration covers multiple biosimilar products to be manufactured at LOTTE Biologics’ Syracuse facility in New York Strategic long-term partnership to increase Alvotech’s global manufacturing capacity and support growth in demand REYKJAVIK, Iceland, and SEOUL, South Korea, Oct. 06, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and LOTTE Biologics, a contract development and manufacturing (CDMO) organization, today announced a long-term strategic manufacturing partnership. Under the agreement, LOTTE Biologics will manufacture drug substance for multiple antibody biosimilar products at its Syracuse facility in New York for global supply, with the potential to further expand the collaboration over time. The Syracuse facility has 40,000 liters of bioreactor capacity for biologics manufacturing, supported by on-site process development and quality control capabilities. The site has an established track record in commercial biologics manufacturing and recently completed an unannounced FDA inspection with zero observations, further demonstrating its strong quality and regulatory capabilities. The agreement expands Alvotech’s US-based manufacturing footprint while strengthening its global supply network. The additional capacity complements Alvotech’s existing manufacturing partnerships and its in-house development and manufacturing capabilities, supporting its expanding portfolio and providing greater flexibility to meet demand across international markets. “Alvotech has one of the most comprehensive, internally developed product portfolios in the industry,” said Lisa Graver, CEO of Alvotech. “With the expansion of our global manufacturing network, we will have sufficient capacity to meet demand for our pipeline for the next ten years. Our collaboration with LOTTE Biologics will bring additional manufacturing capacity in New York to support patients worldwide, complementing our existing capabilities as we scale our portfolio and prepare for future launches.” “Alvotech’s expertise in biosimilar development, combined with LOTTE Biologics’ manufacturing capabilities, creates a strong foundation for this collaboration,” said James Park, CEO of LOTTE Biologics. “We look forward to strategically supporting Alvotech’s growing portfolio and the reliable supply of high-quality, more affordable biologic medicines to patients worldwide. With our Syracuse operations and the completion of our Songdo Bio Campus, we are committed to providing flexible, dual-site manufacturing support as the partnership grows.” Commercial supply will be subject to successful technology transfer, manufacturing qualification and applicable regulatory approvals. For further information, contact: Media Benedikt Stefansson Sarah MacLeod alvotech.media@alvotech.com Investors Dr. Balaji V Prasad Benedikt Stefansson Mikaela Vilchez alvotech.ir@alvotech.com About Alvotech Alvotech is a biotechnology 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. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, 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. For more information, please visit None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our website or follow us on social media on LinkedIn , Facebook , Instagram , and YouTube . About LOTTE Biologics LOTTE Biologics is a global contract development and manufacturing organization (CDMO) providing an integrated biologics solutions to pharmaceutical and biotechnology companies worldwide. With its established commercial manufacturing operations in Syracuse, New York, and the newly completed Songdo Bio Campus in South Korea, LOTTE Biologics is building a flexible, dual-site manufacturing network to support customers from development through commercial supply. For more information, please visit our website or Linkedin . 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 include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. 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 factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time 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. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. 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. A photo accompanying this announcement is available at

2026-10-05

·BioSpace

FDA approves additional U.S. manufacturing capacity for SIMLANDI®, Alvotech’s biosimilar to Humira®

Approval enables AVT02 drug substance for U.S. commercial supply to be manufactured in either of Alvotech’s two Reykjavik drug substance suites Further confirms resolution of FDA inspection-related matters at the Reykjavik site REYKJAVIK, Iceland (October 5, 2026) - Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplement to the Biologics License Application (BLA) for AVT02 (adalimumab-ryvk), marketed in the U.S. as SIMLANDI®, enabling drug substance for the product to be manufactured in a second production suite at the company’s Reykjavik facility. This approval further confirms resolution of inspection-related matters at the Reykjavik site. “This approval is important both operationally and as a further regulatory milestone for our Reykjavik facility,” said Lisa Graver, Chief Executive Officer of Alvotech. “The addition of DSM2 effectively doubles the drug substance manufacturing capacity available to support U.S. supply and provides greater flexibility for commercial supply of AVT02 to the U.S. market. It also reflects the significant progress our teams have made in strengthening quality systems and manufacturing operations at the site.” The second suite, DSM2, supports the complete drug substance manufacturing process, including cell culture and purification, and doubles Alvotech’s manufacturing capacity available to support U.S. supply. DSM2 is already approved for the manufacture of commercial drug substance for European markets, including for AVT02, AVT03, and AVT05. Following the FDA approval, Alvotech can now manufacture AVT02 drug substance for U.S. commercial supply in either DSM1 or DSM2, providing additional capacity and greater flexibility across its manufacturing operations. The approval follows the FDA’s July 2026 closure of its most recent inspection of the Reykjavik facility with a Voluntary Action Indicated (VAI) classification. Alvotech therefore expects the FDA to be able to take action on other pending applications associated with the facility according to their respective goal dates. These include BLAs for AVT05, Alvotech’s proposed biosimilar to Simponi® and Simponi Aria® (golimumab), AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept), AVT03, Alvotech’s proposed biosimilar to Prolia® and Xgeva® (denosumab) and AVT16/AVT80, Alvotech’s proposed biosimilars to Entyvio® (vedolizumab). Each application remains subject to the FDA’s individual review and regulatory decision. About AVT02 / SIMLANDI® (adalimumab-ryvk) AVT02 is a monoclonal antibody approved as a biosimilar to Humira® (adalimumab) in more than 50 countries globally, including the United States, Europe, Canada and Australia. It is currently marketed in the U.S. as SIMLANDI® and under private label, in Europe as HUKYNDRA®, in Canada as SIMLANDI® and in Australia as ADALACIP®. Teva Pharmaceuticals is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI® in the United States, while Alvotech is responsible for development and manufacturing. For further information, contact: Media Benedikt Stefansson Sarah MacLeod alvotech.media@alvotech.com Investors Dr. Balaji V Prasad Benedikt Stefansson Mikaela Vilchez alvotech.ir@alvotech.com About Alvotech Alvotech is a biotechnology 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. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, 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. For more information, please visit None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our website or follow us on social media on LinkedIn , Facebook , Instagram , and YouTube . Use of trademarks Third party trademarks are the property of their respective owners. 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 include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. 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 factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time 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. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. 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.

上市批准生物类似药

2026-09-04

·IBD Daily

CGH：克罗恩病患者转换至乌司奴单抗生物类似药后的临床结局

克罗恩病患者转换至乌司奴单抗生物类似药后的临床结局：一项意大利多中心前瞻性队列研究 Clinical Outcomes After Ustekinumab Biosimilar Switching in Crohn’s Disease: the USBIOS IG-IBD Study Clinical Gastroenterology and Hepatology PMID: 42660257 IF: 6.6 Q1 B2[IF=16.2]B2 背景乌司奴单抗是中重度克罗恩病 (CD) 的重要治疗药物。随着生物制剂在炎症性肠病 (IBD) 治疗中的应用不断增加，长期使用先进治疗所带来的经济负担也成为医疗卫生系统需要考虑的问题。生物类似药通过降低治疗成本、提高药物可及性，为改善医疗资源配置提供了新的选择。目前，多种乌司奴单抗生物类似药已基于分析相似性、药代动力学相似性以及敏感人群中的临床试验等整体证据获得批准，并在机制和整体可比性得到支持的情况下将适应症外推至IBD。然而，监管层面的生物类似性并不能完全替代真实世界中针对特定疾病和具体临床场景的转换证据。尤其对于已经长期接受原研乌司奴单抗治疗并保持稳定的CD患者，因非医学原因转换至生物类似药后能否继续维持疗效和安全性，仍缺乏具有同期原研药对照的前瞻性数据。方法研究纳入年龄≥18岁、接受原研乌司奴单抗治疗至少8个月、处于临床缓解状态 [Harvey-Bradshaw指数 (HBI) <5]，且基线前至少8个月未接受全身性或低生物利用度糖皮质激素治疗的CD患者。患者是否转换药物完全由不同地区采购框架协议或招标政策的实施时间决定，而非研究者根据患者特征进行治疗分配。在已经实施生物类似药采购的地区，患者由原研乌司奴单抗转换至SB17、CT-P43 或AVT04；尚未实施相关采购政策地区的患者继续使用原研乌司奴单抗。主要比较采用扩展的5组分“临床成功”复合终点，即随访6个月时同时满足HBI<5、未使用全身性糖皮质激素、未停用抗白细胞介素-12/23治疗、未发生IBD相关住院以及未接受IBD相关肠道手术。研究预先设定的非劣效界值为-15%。结果 6个月时，扩展临床成功终点数据完整的患者共455例。生物类似药转换组332例患者中306例达到临床成功，比例为92.2%；原研药维持组123例患者中114例达到临床成功，比例为92.7%。两组临床成功率几乎相同，风险差为-0.5%, 95% CI -5.9%-4.9%，其95% CI下限不仅高于预设的-15%非劣效界值，也高于研究完成后增加的更严格-10%参考界值，因此满足研究设定的非劣效标准。对应效应估计为OR 0.93, 95% CI 0.42-2.04, P=0.855。按照研究方案原先定义的3组分临床成功终点，即仅要求HBI<5、未使用全身性糖皮质激素且未停用抗白细胞介素-12/23治疗，两组结果同样一致：转换组为93.1%，原研药组为93.6%，风险差为-0.5%, 95% CI -5.6%-4.6%。这一结果进一步支持主要分析的稳定性。图1：可视化摘要图源：参考文献 [1] 转换生物类似药临床缓解未受明显影响单独分析临床结局时，两种治疗策略之间未观察到明显差异。6个月时，转换组和原研药组的无糖皮质激素临床缓解率分别为94.9%和95.2% (OR 0.95, 95% CI 0.36-2.46, P=0.909)；HBI<5所定义的临床缓解率分别为96.1%和96.8% (OR 0.82, 95% CI 0.26-2.58, P=1.000)。因此，对于已经接受原研乌司奴单抗长期维持治疗、疾病状态稳定且至少8个月无需糖皮质激素的CD患者，因采购政策转换至已获批的乌司奴单抗生物类似药并未在6个月内造成可检测的临床控制下降。研究进一步采用倾向评分逆概率治疗加权，以降低两组基线特征不均衡对结果的影响。加权后，转换组和原研药组临床成功率分别为93.4%和93.8%，加权风险差为-0.4%，转换与临床失败的关联为OR 1.08, 95% CI 0.40-2.89, P=0.884。校正结果与主要分析方向一致，提示已测量的基线差异不足以解释两组观察到的临床结局。生化及客观炎症指标未提示转换后疾病活动反弹临床症状稳定并不等同于肠道炎症完全消失，因此研究同时评价了C反应蛋白 (CRP)、粪便钙卫蛋白 (FC)、肠道超声 (IUS) 及内镜检查结果。 6个月时，以CRP<0.5 mg/dL且FC<250 μg/g同时满足作为生化缓解标准，转换组和原研药组的复合生化缓解率分别为50.2%和51.5% (OR 0.95, 95% CI 0.59-1.53, P=0.828)。基线至6个月的HBI、CRP及FC配对分析均未显示明确变化。在具有配对IUS数据的患者中，转换组53例患者均未出现肠壁厚度由≤3 mm进展至>3 mm，原研药组54例中53例未出现此类恶化；血流信号方面，转换组50例中47例、原研药组54例中53例未出现新的血管化。181例具有配对内镜资料的患者中，转换组115例中113例未出现新发溃疡，原研药组66例中65例未出现新发溃疡。这些结果提示，在现有可获得的客观检查中，没有发现生物类似药转换导致系统性炎症反弹的信号。生物类似药治疗持续率较高在334例具有治疗持续性资料的转换患者中，313例在6个月时仍继续使用最初转换的生物类似药，治疗持续率达到93.7%。仅4例患者转换回原研乌司奴单抗，转换回原研药比例为1.2%。转换组与原研药组的抗白细胞介素-12/23治疗停用率分别为3.6%和1.6%，系统性糖皮质激素使用率分别为1.8%和1.6%，IBD相关住院率分别为1.2%和1.6%，IBD相关肠道手术率分别为0.9%和0。这些事件在两组中的绝对发生率均较低。安全性方面，转换组337例患者中记录到2例不良事件 (0.6%)，原研药组未记录不良事件，P=1.000。两例不良事件均发生于CT-P43治疗患者，分别表现为伴味觉异常的口腔烧灼感以及病因尚不明确的瘙痒性斑丘疹。6个月随访期间未观察到明确的新的短期安全性信号。不过，该研究的不良事件来自临床医生常规记录，而非专门的药物警戒体系，因此仍不能据此评价低频或迟发性安全风险。图2：六个月的疗效和非劣性结果图源：参考文献 [1] (A) 按治疗策略分类的部分六个月临床、生化和安全性结果；(B) 临床和复合终点的风险差及95%置信区间。结论本研究表明，在已经接受原研乌司奴单抗长期治疗并保持临床稳定的CD成人患者中，因地区采购政策转换至已获批乌司奴单抗生物类似药后，临床缓解、生化缓解、治疗持续性、住院、手术以及现有客观炎症指标亦未显示明显不利影响。这些结果为临床稳定CD患者在规范监测下实施乌司奴单抗生物类似药转换提供了真实世界依据，但并不能证明治疗等效性或长期可互换性。对于长期治疗持续性、免疫原性、结构性肠道损伤、迟发性不良事件以及多次转换后的结局，仍需要更长期、采用标准化客观疾病监测的研究进一步验证。致谢中南大学湘雅三医院周婧美中南大学湘雅三医院王思丹中南大学湘雅三医院陈杰中南大学湘雅三医院王晓艳对本篇文章解读做出的贡献题图来源于网络参考文献 1. Ribaldone DG, Tribocco E, Scaldaferri F, et al. Clinical Outcomes After Ustekinumab Biosimilar Switching in Crohn's Disease: the USBIOS IG-IBD Study. Clin Gastroenterol Hepatol. Published online August 27, 2026. doi:10.1016/j.cgh.2026.08.014 投稿征集欢迎各位专家分享您的研究成果投稿邮箱：med_chenjie@csu.edu.cn 我们是一群热心于IBD研究的青年医生为您每天分享一个炎症性肠病的小知识免责声明：本平台旨在分享最新科研资讯，所载内容和意见仅供专业人士参考，不构成任何诊疗建议。在任何情况下，作者及作者所在团队不对任何人因使用本平台中的任何内容所致的任何损失负任何责任。本资料难以设置访问权限，若给您造成不便，还请见谅。本文属于医学专业文章，仅供医疗专业人员学术交流。不适合作为非专业人士疾病教育或科普用途。若有转载、合作、投稿需求，请联系团队负责人(邮箱：med_chenjie@csu.edu.cn)。本团队未创建任何交流群，请读者朋友谨防诈骗。

生物类似药临床1期带量采购

100 项与乌司奴单抗生物类似药（Alvotech）相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AC05	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
活动性重度溃疡性结肠炎	美国	Alvotech USA, Inc.	2024-10-18
活动性中度溃疡性结肠炎	英国	Genus Pharmaceuticals Ltd.	2024-03-26
银屑病	欧盟	Alvotech	2024-01-10
银屑病	冰岛	Alvotech	2024-01-10
银屑病	列支敦士登	Alvotech	2024-01-10
银屑病	挪威	Alvotech	2024-01-10
活动性中度克罗恩病	欧盟	STADA Arzneimittel AG	2024-01-05
活动性中度克罗恩病	冰岛	STADA Arzneimittel AG	2024-01-05
活动性中度克罗恩病	列支敦士登	STADA Arzneimittel AG	2024-01-05
活动性中度克罗恩病	挪威	STADA Arzneimittel AG	2024-01-05
活动性重度克罗恩病	欧盟	STADA Arzneimittel AG	2024-01-05
活动性重度克罗恩病	冰岛	STADA Arzneimittel AG	2024-01-05
活动性重度克罗恩病	列支敦士登	STADA Arzneimittel AG	2024-01-05
活动性重度克罗恩病	挪威	STADA Arzneimittel AG	2024-01-05
克罗恩病	加拿大	JAMP Pharma Corp.	2023-11-01
银屑病关节炎	日本	Fuji Pharma Co., Ltd.	2023-09-25
斑块状银屑病	日本	Fuji Pharma Co., Ltd.	2023-09-25

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04930042 (AVT04-GL-301, FDA_CDER) 人工标引	临床3期	银屑病关节炎	927	UstekinumabUstekinumab 45 mg (PsA STUDY 1)	製壓構膚顧鹽遞鏇窪齋(齋觸選醖糧鑰鹽衊醖夢) = 鹹獵淵醖顧憲淵衊簾壓餘艱淵觸鬱簾選範餘範 (廠鬱糧願範齋憲餘窪鬱 ) 更多	积极	2024-04-16
				Ustekinumab 90 mgUstekinumab90 mg (PsA STUDY 1)	製壓構膚顧鹽遞鏇窪齋(齋觸選醖糧鑰鹽衊醖夢) = 餘艱齋鑰窪鏇構網壓淵餘艱淵觸鬱簾選範餘範 (廠鬱糧願範齋憲餘窪鬱 ) 更多
NCT04930042 (AVT04-GL-301, FDA_CDER) 人工标引	临床3期	斑块状银屑病	2,069	Placebo (Ps STUDY 1 + Adult)	淵範艱願襯簾築簾鏇觸(鑰憲築顧夢壓艱鬱壓醖) = 膚繭構願襯遞艱築糧壓窪製範鹽餘齋簾製選鏇 (壓觸淵淵鹹觸憲齋窪齋 ) 更多	积极	2024-04-16
				Ustekinumab 45 mg (Ps STUDY 1 + Adult)	淵範艱願襯簾築簾鏇觸(鑰憲築顧夢壓艱鬱壓醖) = 顧膚築糧衊築願廠簾鹽窪製範鹽餘齋簾製選鏇 (壓觸淵淵鹹觸憲齋窪齋 ) 更多
NCT04930042 (Pubmed \| Expert Opin Biol Ther)	临床3期	斑块状银屑病	581	AVT04	網蓋蓋顧蓋壓鹽衊範壓(觸鹽網糧壓顧鬱顧積廠) = 齋鬱繭獵膚夢膚窪製餘壓廠積構廠夢廠構糧膚 (繭壓餘壓觸齋鹽選繭襯 )	积极	2023-07-12
				Reference product ustekinumab (Stelara®)	網蓋蓋顧蓋壓鹽衊範壓(觸鹽網糧壓顧鬱顧積廠) = 製製網網餘鬱鏇膚餘餘壓廠積構廠夢廠構糧膚 (繭壓餘壓觸齋鹽選繭襯 )
NCT04930042 (AAD2023)	临床3期	银屑病	581	AVT04	鑰窪糧艱蓋餘艱壓廠憲(壓鑰範鹽膚鏇齋鏇繭餘) = 製糧夢廠夢衊遞膚繭窪鬱艱繭廠鑰網顧憲膚憲 (遞選網壓網獵鑰鹽壓鏇 ) 更多	-	2023-03-17
				Reference Ustekinumab	鑰窪糧艱蓋餘艱壓廠憲(壓鑰範鹽膚鏇齋鏇繭餘) = 選獵淵鹹夢鏇膚築選憲鬱艱繭廠鑰網顧憲膚憲 (遞選網壓網獵鑰鹽壓鏇 ) 更多