A Randomized, Double-Blind, Parallel-Group, Phase I Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 s.c. Compared to Actemra® in Healthy Male Participants

The primary objective of the study is to show equivalence in pharmacokinetics (PK) of BIIB800 and Actemra following SC administration of a single dose to healthy male participants. The secondary objective of the study is to evaluate PK over time, clinical safety, pharmacodynamic (PD) profiles and immunogenicity of BIIB800 and Actemra.

开始日期2024-01-02

申办/合作机构

Biogen, Inc.

CTR20232409

/ Active, not recruiting临床1期

一项随机、双盲、单次给药、平行两组BAT1806皮下注射液与雅美罗®在中国健康男性受试者的药代动力学和安全性比对研究

主要研究目的：比较在中国健康男性受试者中单次皮下注射BAT1806皮下注射液或雅美罗®（欧盟），两药之间药代动力学的相似性。次要研究目的：评价BAT1806皮下注射液、雅美罗®（欧盟）在中国健康男性受试者的临床安全性、耐受性及免疫原性。

开始日期2023-08-29

申办/合作机构

百奥泰生物制药股份有限公司

NCT05968508

/ Active, not recruiting临床1期

A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects

This is a randomized, double-blind, single-dose, two-arm parallel study to compare the pharmacokinetics, safety and immunogenicity of BAT1806 prefilled subcutaneous injection with RoActemra® (from EU) in healthy male subjects.

开始日期2023-08-29

申办/合作机构

百奥泰生物制药股份有限公司

100 项与托珠单抗生物类似药 (百奥泰生物) 相关的临床结果

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100 项与托珠单抗生物类似药 (百奥泰生物) 相关的转化医学

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100 项与托珠单抗生物类似药 (百奥泰生物) 相关的专利（医药）

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项与托珠单抗生物类似药 (百奥泰生物) 相关的文献（医药）

2025-03-01·BIODRUGS

Comparative Structure Activity Relationship Characterization of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab

Article

作者: Liu, Cuihua ; Ebbers, Hans C ; Liu, Suli ; Li, Shengfeng ; Mei, Xiong ; Liu, Yujie ; Xie, Jianhua ; Cao, Di ; Li, Zhuxiang ; Engle, Linda

BACKGROUND:

BAT1806/BIIB800 (Tofidence™/tocilizumab-bavi), a biosimilar of tocilizumab, demonstrated a high degree of analytical and functional similarity to reference tocilizumab (TCZ) in a comprehensive comparative analytical assessment. Minor differences with respect to TCZ were observed for some attributes and this study assessed the potential impact of these differences through structure activity relationship characterization.

METHODS:

Structure activity relationship studies were conducted to assess glycation, glycosylation, charge variants, hydrophobicity, oxidation, and deamidation differences, using a range of investigative techniques. Structure activity relationship studies were performed on one lot each of BAT1806/BIIB800 and TCZ (European Union sourced only) except for glycation, where additional lots sourced from China and the USA were used.

RESULTS:

Average total glycated protein content of BAT1806/BIIB800 was higher than TCZ (10.08% vs 1.19%); however, biological activity, including target binding and functional potency, was unaffected. Stress-induced glycation of BAT1806/BIIB800 and TCZ also did not affect the biological activity of the products despite up to 60% total glycation content. Minor differences were observed between BAT1806/BIIB800 and TCZ in glycosylation, charge variants, hydrophobicity, oxidation, and deamidation without a relevant impact on interleukin-6 receptor binding, Fc-receptor binding, and effector functions. In forced degradation studies, oxidation and deamidation trends were comparable between the two products.

CONCLUSIONS:

Comparative structure activity relationship characterization of BAT1806/BIIB800 and TCZ indicated that there are no relevant differences in quality attributes between BAT1806/BIIB800 and reference TCZ. Observed differences between BAT1806/BIIB800 and TCZ had no functional impact on BAT1806/BIIB800. The results support the conclusion that BAT1806/BIIB800 is similar to TCZ.

2024-09-01·BIODRUGS

Correction to: Demonstration of Physicochemical and Functional Similarity of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab

2024-07-01·BIODRUGS

Demonstration of Physicochemical and Functional Similarity of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab

Article

作者: Ebbers, Hans C ; Liu, Cuihua ; Li, Shengfeng ; Liu, Suli ; Mei, Xiong ; Xie, Jianhua ; Cao, Di ; Liu, Yujie ; Li, Zhuxiang ; Engle, Linda

BACKGROUND AND OBJECTIVE:

Tocilizumab is an immunoglobulin G1 monoclonal antibody targeting the interleukin-6 receptor (IL-6R). BAT1806/BIIB800 (tocilizumab-bavi) has been developed as a biosimilar to the reference product tocilizumab (TCZ). The objective of this study was to demonstrate physicochemical and functional similarity between BAT1806/BIIB800 and TCZ in a comprehensive comparability exercise.

METHODS:

A comprehensive panel of over 20 methods was used to generate datasets comparing critical and non-critical product quality attributes for 10 BAT1806/BIIB800 lots and 44 TCZ lots (16 sourced from China, 16 from the EU, and 12 from the US). Primary structure, higher-order structure, and physicochemical properties were assessed using liquid chromatography, mass spectrometry, various spectroscopy techniques/methods, capillary electrophoresis, and thermoanalytical techniques. Fragment antigen-binding (Fab)- and fragment crystallizable (Fc)-mediated biological properties were assessed using cell-based assays, immunoassays, flow cytometry, and kinetic binding assays.

RESULTS:

BAT1806/BIIB800 and TCZ (irrespective of source) were shown to be similar in terms of structural and functional properties. No differences were observed in terms of the most critical quality attributes, that is, soluble-IL-6R binding and inhibition of IL-6-mediated cell proliferation. BAT1806/BIIB800 and TCZ demonstrated similarity in terms of Fab- and Fc-mediated binding and biological activity. Minor differences were observed in glycosylation (afucosylation and sialylation), glycation, aggregation, and charge variants, which were demonstrated to be not clinically relevant.

CONCLUSION:

BAT1806/BIIB800 and TCZ were highly similar for all critical quality attributes. Where differences were observed in less critical quality attributes, additional analytical assessments and clinical study results determined these to be not clinically meaningful.

210

项与托珠单抗生物类似药 (百奥泰生物) 相关的新闻（医药）

2025-04-02

·PipelineReview

Organon Acquires TOFIDENCE™ (tocilizumab-bavi), a Commercialized Biosimilar to ACTEMRA® (tocilizumab) Injection, for Intravenous Infusion in the U.S.

Strengthens and expands U.S. biosimilars immunology portfolio with multi-indication arthritis treatment JERSEY CITY, NJ, USA I April 01, 2025 I Organon (NYSE: OGN), a global healthcare company with a deep expertise in biosimilars, today announced that it has acquired from Biogen Inc. (Nasdaq: BIIB) regulatory and commercial rights in the U.S. for TOFIDENCE ™ , a biosimilar to ACTEMRA ® , for intravenous infusion. TOFIDENCE, the first approved tocilizumab biosimilar entrant in the U.S. market, was launched in May 2024 and is indicated in certain patients for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19. “Biosimilars continue to be a key growth driver for Organon, and this acquisition complements our existing business, enabling us to expand our immunology portfolio,” said Kevin Ali, Organon’s Chief Executive Officer. “We believe that by leveraging our commercial expertise and market access capabilities, there is considerable growth potential for this product.” Under the terms of the agreement, Organon has acquired the regulatory and commercial rights to TOFIDENCE in the U.S., available in three vial sizes, 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL, for further dilution prior to intravenous infusion. Bio-Thera Solutions Ltd., the product developer, will maintain manufacturing rights for TOFIDENCE for the U.S. market. The agreement includes an upfront payment to Biogen, with Organon assuming the obligation to pay tiered royalty payments based on net sales and tiered annual net sales milestone payments owed by Biogen to Bio-Thera Solutions Ltd. ABOUT TOFIDENCE (tocilizumab-bavi) TOFIDENCE (tocilizumab) is a treatment developed as a biosimilar to the reference product ACTEMRA. TOFIDENCE is indicated for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and Coronavirus Disease 2019. INDICATIONS AND USAGE Rheumatoid Arthritis (RA) TOFIDENCE is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA) TOFIDENCE is indicated for the treatment of giant cell arteritis in adult patients. Polyarticular Juvenile Idiopathic Arthritis (PJIA) TOFIDENCE is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Systemic Juvenile Idiopathic Arthritis (SJIA) TOFIDENCE is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Coronavirus Disease 2019 (COVID-19) TOFIDENCE is indicated for the treatment of coronavirus disease 2019 in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Before prescribing, please read the full Prescribing Information. About Organon Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers over 70 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. Organon is also pursuing opportunities to collaborate with biopharmaceutical partners and innovators who look to commercialize their products by leveraging Organon’s scale and agile presence in fast growing international markets. Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. For more information, visit http://www.organon.com and connect with us on LinkedIn , Instagram , X (formerly known as Twitter) and Facebook . SOURCE: Organon

上市批准并购引进/卖出生物类似药

2025-04-02

·GBIHealth

国家卫健委：做好2025年基层卫生健康综合试验区重点工作

药械追踪No.1 / 辉瑞RSV疫苗获欧盟批准扩大适应证至18-59岁人群2025年4月2日，辉瑞（NYSE:PFE）宣布，呼吸道合胞病毒（RSV）疫苗Abrysvo已获欧盟委员会（EC）批准扩展适应证，将针对60岁及以上人群的适应证扩展至包括预防18至59岁人群因RSV导致的下呼吸道疾病（LRTD）。关键性III期临床试验（NCT05842967）MoNeT的积极结果支持了此次扩展适应证的批准。Abrysvo是一款无佐剂二价疫苗，目前在欧盟拥有最广泛的RSV疫苗适应证，具体包括：为18岁及以上人群提供主动免疫，预防由RSV引起的LRTD；为孕期24至36周的孕妇接种，为出生后至6个月内的婴儿提供针对RSV引起的LRTD的被动保护。->点击文末阅读原文，解锁完整双语新闻No.2 / 华东医药司美格鲁肽生物类似药上市申请获NMPA受理2025年4月2日，华东医药（000963.SZ）发布公告称，子公司江东公司的司美格鲁肽注射液上市申请获国家药监局受理，用于成人2型糖尿病患者的血糖控制。司美格鲁肽注射液是一种长效胰高血糖素样肽-1（GLP-1）受体激动剂，与人GLP-1有94%的序列同源性，临床上主要用于2型糖尿病患者的血糖控制、肥胖或超重患者的长期体重管理。司美格鲁肽注射液的原研企业为诺和诺德，目前国内仅有诺和诺德的司美格鲁肽获批上市。其他还有齐鲁制药、九源基因、丽珠集团在国内提交司美格鲁肽上市申请。->点击文末阅读原文，解锁完整双语新闻企业动态No.1 / 欧加隆收购百奥泰托珠单抗生物类似药静脉注射剂美国商业化权益2025年4月1日，百奥泰生物制药股份有限公司（688177.SH）宣布，欧加隆自渤健收购了百奥泰托珠单抗生物类似药TOFIDENCE的美国商业化权益。此前，百奥泰曾于2021年4月将TOFIDENCE在除中国地区（包括中国大陆及港澳台）以外的全球市场的独占的产品权益许可给渤健。后续欧加隆将负责TOFIDENCE在美国的市场和销售等相关商业化活动，百奥泰将负责TOFIDENCE的生产和商业化供应。欧加隆将承担渤健在2021年的授权协议中基于净销售额和年度净销售额向百奥泰支付分级特许权使用费和里程碑付款的义务。TOFIDENCE于2024年5月获FDA批准，是美国市场首个获批的托珠单抗生物类似药。其适用于治疗中度至重度活动性类风湿性关节炎、巨细胞动脉炎、多关节幼年特发性关节炎、系统性幼年特发性关节炎、COVID-19感染等适应证。->点击文末阅读原文，解锁完整双语新闻行业政策No.1 / 国家卫健委：做好2025年基层卫生健康综合试验区重点工作2025年4月1日，国家卫生健康委办公厅发布关于做好2025年基层卫生健康综合试验区重点工作的通知，要求地方各级卫生健康行政部门指导试验区深入学习三明医改经验和基层卫生健康综合试验区首批改革创新典型经验，促进“三医”协同发展和治理，深化体制机制改革，推动分级诊疗体系建设。国家和省级试验区要率先高标准落实基层卫生健康年度重点工作：①加强县域医疗卫生服务体系和基层医疗卫生服务能力建设，2025年底前实现乡镇卫生院和社区卫生服务中心县级医院人员派驻全覆盖、提供儿童常见疾病诊疗服务全覆盖。②积极开展家庭医生“签约有感”行动，推行签约个性化服务包并落实签约费用，签约覆盖率比上年度提高1-3个百分点。③优化慢性病患者连续服务，推动慢性病、肥胖症等膳食、运动指导要点嵌入基层医疗服务。国家试验区要主动改革创新，发挥示范引领作用：①完善医保支持分级诊疗政策和县域医共体人员下沉长效保障机制，优化绩效分配方案。②探索将签约居民的医保门诊统筹基金按人头支付给家庭医生（团队），合理测算签约服务费结算标准，将不低于70%的签约服务费用于签约服务人员薪酬。③全面推动存量乡村医生“乡聘村用”，加快乡村医生向执业（助理）医师转变，提高村卫生室运行补助和乡村医生岗位补助。④2025年每个试验区培养医防管复合型人才人数不少于30人。⑤推动建立营养评估与营养指导、运动评估与运动指导等服务收费机制。⑥发挥村（居）民委员会公共卫生委员会作用，将基层卫生健康工作融入村（社区）网格，促进社会共治。->点击阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ xujingou@baidu.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

并购临床3期生物类似药上市批准疫苗

2025-04-02

·Pharmaceutical Technology

Organon acquires Actemra biosimilar’s US rights from Biogen

The move is set to bolster and widen Organon’s US biosimilars immunology portfolio with multi-indication arthritis treatment. Credit: testing/Shutterstock. Organon has announced the acquisition of the US regulatory and commercial rights for intravenous infusion of the Actemra biosimilar, Tofidence, from Biogen. The move is set to bolster and widen Organon’s US biosimilars immunology portfolio with multi-indication arthritis treatment. Launched in May 2024, Tofidence is available in three vial sizes: 80 mg/4 mL, 200 mg/10 mL and 400 mg/20 mL, for further dilution before intravenous infusion. It is the first tocilizumab biosimilar to enter the US market, and treats systemic juvenile idiopathic arthritis, moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and Covid-19. Organon will make an upfront payment to Biogen and is committed to making tiered royalty payments based on net sales and milestone payments to Bio-Thera Solutions. Bio-Thera Solutions, the developer of Tofidence, will continue to have the manufacturing rights for the biosimilar in the US market. Organon CEO Kevin Ali stated, “Biosimilars continue to be a key growth driver for Organon, and this acquisition complements our existing business, enabling us to expand our immunology portfolio. “We believe that by leveraging our commercial expertise and market access capabilities, there is considerable growth potential for this product.” In September 2023, Biogen announced the receipt of US Food and Drug Administration (FDA) approval for Tofidence. The biosimilar’s commercialisation and licence agreement between Biogen and Bio-Thera was established in April 2021, granting Biogen exclusive regulatory, manufacturing and commercial rights to Tofidence in all nations except China, inclusive of Taiwan, Macau and Hong Kong. Organon’s portfolio includes medicines and products in therapeutic areas such as women’s health, and biosimilars. The company is headquartered in Jersey City, New Jersey, US. Organon previously completed the acquisition of the Roivant subsidiary, Dermavant Sciences, broadening its dermatology portfolio.

上市批准并购引进/卖出

100 项与托珠单抗生物类似药 (百奥泰生物) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AC07	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
新型冠状病毒感染	欧盟	Biogen Netherlands BV	2024-06-20
新型冠状病毒感染	冰岛	Biogen Netherlands BV	2024-06-20
新型冠状病毒感染	列支敦士登	Biogen Netherlands BV	2024-06-20
新型冠状病毒感染	挪威	Biogen Netherlands BV	2024-06-20
少关节关节炎	欧盟	Biogen Netherlands BV	2024-06-20
少关节关节炎	冰岛	Biogen Netherlands BV	2024-06-20
少关节关节炎	列支敦士登	Biogen Netherlands BV	2024-06-20
少关节关节炎	挪威	Biogen Netherlands BV	2024-06-20
多关节型幼年特发性关节炎	美国	Biogen MA, Inc.	2023-09-29
细胞因子释放综合征	中国	百奥泰生物制药股份有限公司	2023-01-16
类风湿关节炎	中国	百奥泰生物制药股份有限公司	2023-01-16
全身型幼年特发性关节炎	中国	百奥泰生物制药股份有限公司	2023-01-16

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
幼年特发性关节炎	申请上市	美国	百奥泰生物制药股份有限公司	2022-12-09

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临床结果

适应症

分期

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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


NCT03830203 \| EUCTR2018-002202-31-BG (Pubmed \| Arthritis Res Ther)	临床3期	类风湿关节炎	621	TCZ	簾製網鏇遞鑰觸鑰膚繭(憲餘築鏇獵願簾餘構遞) = 構觸觸餘憲選繭鬱鹽鬱鏇鹽衊製蓋餘淵顧獵獵 (糧醖窪醖選範壓艱鹽鏇 )	积极	2024-09-07
				TCZ to BAT1806/BIIB800	簾製網鏇遞鑰觸鑰膚繭(憲餘築鏇獵願簾餘構遞) = 夢夢獵蓋範齋鹽窪範範鏇鹽衊製蓋餘淵顧獵獵 (糧醖窪醖選範壓艱鹽鏇 )
NCT03830203 \| EUCTR2018-002202-31-BG (Pubmed 1 \| Pubmed 2 \| Lancet Rheumatol) 人工标引	临床3期	类风湿关节炎	621	BAT1806	範鏇鑰夢鑰繭願網選鹽(鹹範餘簾襯獵衊窪築鏇) = 遞鑰鹹簾壓範蓋糧憲鹽糧膚鑰廠壓壓淵遞餘簾 (築遞膚顧遞壓襯積糧夢 ) 更多	相似	2024-01-01
				tocilizumab	範鏇鑰夢鑰繭願網選鹽(鹹範餘簾襯獵衊窪築鏇) = 壓糧窪遞積廠範網願壓糧膚鑰廠壓壓淵遞餘簾 (築遞膚顧遞壓襯積糧夢 ) 更多
CTR20180039 \| NCT03606876 (Pubmed \| Front Pharmacol) 人工标引	临床1期	-	138	BAT1806	憲襯網壓艱糧構壓鹽齋(構鹽蓋選鑰憲鬱鹹醖願) = similar in all three groups: BAT1806 (n = 45), RoActemra-EU (n = 42), and Actemra-US (n = 42). The 90% confidence intervals (CIs) for the ratios of C max , AUC0-t and AUC0-∞ were 86.90-104.41% for BAT1806 vs. RoActemra-EU, 91.70-106.15% for BAT1806 vs Actemra-US, and 90.04-105.53% for Actemra-US vs RoActemra-EU. For all comparisons, the 90% CIs for the C max , AUC0-t , and AUC0-∞ were within the predefined bioequivalence limit of 80.00-125.00%. 襯積顧齋夢積鹹膚鹽顧 (繭鑰鹽齋糧憲鏇網積簾 )	相似	2020-01-01
				RoActemra-EU