A Phase 1, Randomized, Open-label, 2-arm, Parallel Design Study in Normal Healthy Subjects to Evaluate Pharmacokinetics, Safety, and Tolerability of Bmab 1200 -Autoinjector (Biosimilar Ustekinumab) After Single Subcutaneous Injection in Comparison With Bmab 1200 -Prefilled Syringe (Biosimilar Ustekinumab)

This is an open-label, 2-arm parallel-group study in normal healthy subjects to evaluate pharmacokinetics, safety, tolerability of Bmab 1200 -autoinjector (AI) after single subcutaneous injection (45 mg) in comparison with Bmab 1200 -prefilled syringe (PFS).

开始日期2025-01-09

申办/合作机构

Biocon Ltd.

CTRI/2024/12/077726

/ Not yet recruiting临床1期

A phase 1, randomized, open-label, 2-arm, parallel design study in normal Healthy subjects to evaluate pharmacokinetics, safety, and tolerability of Bmab 1200 -autoinjector (biosimilar ustekinumab) after single Subcutaneous injection in comparison with Bmab 1200 -prefilled syringe(biosimilar ustekinumab) - NIL

开始日期2024-12-15

申办/合作机构

Biocon Biologics Ltd. (India)

NCT05335356

/ Completed临床3期

A Randomized, Double-Blind, Parallel Group, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis

This is a randomized, double-blind, active-controlled, parallel-group, multicenter study designed to compare the efficacy, safety, immunogenicity, and PK(Pharmacokinetic) of Bmab 1200 with Stelara in adult patients with moderate to severe chronic plaque psoriasis.

开始日期2022-06-28

申办/合作机构

Biocon Ltd.

100 项与乌司奴单抗生物类似药 (Biocon) 相关的临床结果

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100 项与乌司奴单抗生物类似药 (Biocon) 相关的转化医学

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100 项与乌司奴单抗生物类似药 (Biocon) 相关的专利（医药）

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项与乌司奴单抗生物类似药 (Biocon) 相关的文献（医药）

2025-10-03·EXPERT OPINION ON BIOLOGICAL THERAPY

Comparative efficacy and safety of biosimilar Bmab 1200 versus reference ustekinumab in moderate-to-severe plaque psoriasis: 52-week findings from the Phase 3 STELLAR-2 trial

Article

作者: Feldman, Steven R. ; Poder, Airi ; Pulka, Grazyna ; Szepietowski, Jacek C. ; Marwah, Ashwani ; Athalye, Sandeep N. ; Wolff-Holz, Elena ; Loganathan, Subramanian ; Kumar, Kuldeep ; Mekokishvili, Lally ; Singh, Gursharan ; Deodhar, Sarika ; Reich, Adam ; Tsiskarishvili, Nino ; Svarca, Inese

BACKGROUND:

The STELLAR-2 study compared the efficacy, safety, immunogenicity, and pharmacokinetics of Bmab 1200 with reference ustekinumab through Week 52 in patients with moderate-to-severe chronic plaque psoriasis.

RESEARCH DESIGN AND METHODS:

In this double-blind, Phase 3 study, patients were randomized 1:1 to receive Bmab 1200 or reference ustekinumab (45 mg or 90 mg). At Week 16, patients responding to ustekinumab (improvement in Psoriasis Area and Severity Index [PASI] score ≥50%) were re-randomized to continue with reference ustekinumab or switch to Bmab 1200 and followed through Week 52.

RESULTS:

Overall, 324 patients completed the study. At Week 52, the mean (SD) percentage reduction in PASI scores from baseline was -95.5% (7.51) for Bmab 1200, -96.6% (5.67) for continued-reference ustekinumab, and -94.7% (7.95) for switched-to-Bmab 1200 groups. Efficacy and safety outcomes were comparable across groups. From 28 to 52 weeks, 37.8% of patients had at least one treatment-emergent adverse event. The incidence of post-switch antidrug antibodies was also comparable (Bmab 1200: 63.7%; continued-reference ustekinumab: 80.2%; switched-to-Bmab 1200: 72.6%).

CONCLUSIONS:

Bmab 1200 demonstrated clinical biosimilarity to reference ustekinumab through Week 52 even after switching. Long-term comparable efficacy and safety were also maintained.

TRIAL REGISTRATION:

www.clinicaltrials.gov identifier is NCT05335356 and www.clinicaltrialsregister.eu identifier is 2021-006668-25.

2025-08-03·EXPERT OPINION ON BIOLOGICAL THERAPY

Efficacy and safety of the ustekinumab biosimilar, Bmab 1200, versus reference ustekinumab in moderate-to-severe plaque psoriasis: 28‑week results of the randomized, double-blind, Phase 3 STELLAR-2 study

Article

作者: Poder, Airi ; Pulka, Grazyna ; Marwah, Ashwani ; Wolff-Holz, Elena ; Loganathan, Subramanian ; Kumar, Kuldeep ; Mekokishvili, Lally ; Singh, Gursharan ; Deodhar, Sarika ; Reich, Adam ; Feldman, Steven R ; Athalye, Sandeep N ; Szepietowski, Jacek C ; Tsiskarishvili, Nino ; Svarca, Inese

BACKGROUND:

STELLAR-2 assessed the equivalent efficacy of the ustekinumab biosimilar, Bmab 1200, versus reference ustekinumab in patients with moderate-to-severe chronic plaque psoriasis. Safety, immunogenicity, and pharmacokinetics (PK) were also evaluated.

RESEARCH DESIGN AND METHODS:

In this double-blind, parallel-group, Phase 3 study, patients were randomized 1:1 to Bmab 1200 or reference ustekinumab in Treatment Period (TP)1, and at Week 16, those who responded to reference ustekinumab (improvement in Psoriasis Area and Severity Index [PASI] score ≥ 50%) were re-randomized (1:1) to continue reference ustekinumab or switch to Bmab 1200 in TP2. The primary endpoint was the change in PASI from baseline to Week 12. Equivalent efficacy was established if 90% and 95% confidence intervals (CIs) for the treatment difference were within predefined equivalence margins of ± 10% and ± 13%, respectively.

RESULTS:

Overall, 384 patients were randomized (Bmab 1200: N = 191; reference ustekinumab: N = 193) in TP1. At Week 12, the least squares mean treatment difference (0.6800%; 90% CI: -1.27, 2.63; 95% CI: -1.64, 3.00) was within the predefined equivalence margins for 90% and 95% CIs. Safety, immunogenicity, and PK were comparable between treatment groups.

CONCLUSIONS:

Bmab 1200 and reference ustekinumab had similar efficacy, safety, immunogenicity, and PK in patients with moderate-to-severe plaque psoriasis.

TRIAL REGISTRATION:

www.clinicaltrialsregister.eu identifier is 2021-006668-25; www.clinicaltrials.gov identifier is NCT05335356.

2025-04-03·EXPERT OPINION ON INVESTIGATIONAL DRUGS

Pharmacokinetic equivalence and comparative safety, tolerability, and immunogenicity of Biocon’s ustekinumab (Bmab-1200) with EU-approved and US-licensed reference ustekinumab in healthy subjects: results from the Study to Test pharmacokinetic BioEquivalence of BiosimiLar ustekinumab to SteLARa (STELLAR-1)

Article

作者: Kumar, Kuldeep ; Ackroyd, Jonathan ; Athalye, Sandeep Nilkanth ; Panda, Jayanti ; Singh, Gursharan ; Deodhar, Sarika S ; Loganathan, Subramanian ; Marwah, Ashwani

BACKGROUND:

This study assessed the pharmacokinetics (PK) equivalence, safety, tolerability, and immunogenicity of Bmab-1200 versus the reference product ustekinumab (EU-approved and US-licensed Stelara).

RESEARCH DESIGN & METHODS:

This 20-week, randomized, double-blind, three-arm, parallel-design, Phase-1 study enrolled healthy male and female subjects (n = 258; 18-55 years). A single, 45-mg subcutaneous injection of Bmab-1200, EU-approved Stelara, or US-licensed Stelara was administered in a 1:1:1 ratio. Subject stratification was performed by ethnicity, body weight range, and gender. Primary PK endpoints included AUC_0-inf and C_max. Secondary endpoints included additional PK parameters, immunogenicity, and safety and tolerability.

RESULTS:

All three pairwise comparisons of Bmab-1200 versus US-Stelara, Bmab-1200 versus EU-Stelara, and US-Stelara versus EU-Stelara were equivalent for AUC_0-inf (90% confidence intervals [CIs] of the geometric least squares mean [GLSM] ratio: 0.9975-1.1657, 0.9959-1.1685, and 0.9223-1.0921, respectively) and C_max (90% CIs of the GLSM ratio: 0.9478-1.0732, 0.9136-1.0376, and 0.9012-1.0267, respectively). All secondary analyses supported the primary results.

CONCLUSION:

Three-way PK equivalence between Bmab-1200, US-Stelara, and EU-Stelara was demonstrated. A single, 45-mg dose of Bmab-1200 was safe and well tolerated, and, overall, the number of AEs was similar among the groups. Diversity limited to White and Japanese groups did not impact the study results.

CLINICAL TRIAL REGISTRATION:

This study was registered with www.isrctn.com; identifier: ISRCTN11424009.

项与乌司奴单抗生物类似药 (Biocon) 相关的新闻（医药）

2025-11-17

·生物通

美国可互换生物类似药监管路径演变：政策放宽下的审批趋势与市场影响分析

随着生物药在全球医疗支出中的占比持续攀升，生物类似药（Biosimilar）作为原研生物药的高质量替代品，被视为降低医疗成本的关键。然而，生物类似药能否在药房层面直接被替换使用（即“可互换性”interchangeability），一直是监管与临床实践的核心争议点。2019年，美国食品药品监督管理局（FDA）发布指南，要求可互换生物类似药必须通过严格的Ⅲ期临床转换研究（switching studies）证明安全性，这一高标准虽保障了用药安全，却也显著增加了企业开发成本与时间。2024年6月，FDA发布草案指南，提出取消转换研究的强制要求，转而强调分析数据的权重，这一政策松动可能深刻影响生物类似药市场的未来格局。为厘清政策调整前后的实际影响，约翰斯·霍普金斯大学等机构的研究团队分析了2019至2025年间美国可互换生物类似药的审批动态、企业策略与监管效率。研究发表于《Therapeutic Innovation & Regulatory Science》，通过系统梳理FDA Purple Book数据库，揭示了可互换生物类似药审批的加速趋势、企业申报路径的分化，以及政策改革可能带来的市场机遇。研究方法的核心技术路径研究团队于2025年9月提取FDA Purple Book中所有获批可互换生物类似药的生物制品许可申请（BLA）号、生产企业、参照药品（reference product）及批准日期等数据，并结合FDA批准函获取申报时间。通过年度、企业、参照药品分类比对，分析审批数量、时间线及企业策略（同步申报或延迟申报）。所有分析均基于公开监管数据，未涉及实验操作或样本队列。研究结果 1. 可互换生物类似药审批数量激增，龙头企业主导市场自2020年以来，FDA共批准26个可互换生物类似药，其中2024年至2025年9月间获批数量达19个，呈现井喷态势。三星Bioepis、山德士（Sandoz）、Biocon等大型企业分别获得5、4、4项批准，安进（Amgen）和赛尔群（Celltrion）各获3项，反映出龙头企业更早布局可互换赛道。 2. 企业策略分化：同步申报成为高效路径企业申报策略分为两类：17个产品在首次申报BLA时同步申请可互换性，9个产品则在BLA获批后延迟追加。同步申报策略显著缩短了整体审批周期，成为主流选择。 3. 审批时间线大幅缩短，监管效率提升 2020年申报产品的平均审批时间为798天，2024年已缩短至364天，降幅达54%。这一变化体现FDA对可互换性审评流程的优化，尤其是2024年草案指南取消转换研究要求后，未来审批速度有望进一步加快。 4. 多剂型审批普遍，参照药品集中度高 26个可互换生物类似药中，19个获批两种及以上剂型或给药方式，衍生出79个具体产品批准。参照药品集中于少数原研药，乌司奴单抗（ustekinumab）与阿达木单抗（adalimumab）分别有7个和6个可互换类似药获批，提示企业更倾向于针对市场容量大的靶点布局。结论与讨论可互换生物类似药的加速审批与政策放宽，为降低生物药费用、提升用药可及性提供了重要契机。然而，美国市场仍落后于欧洲（欧洲药品管理局EMA已批准92个可互换生物类似药）。研究指出，未来需通过三项关键措施释放市场潜力：一是建立基于复杂度的分级审批路径，简化胰岛素、生长激素等低复杂度产品的准入；二是同步授予生物类似药与可互换资格，消除转换研究带来的延迟；三是加强医患教育，消除对可互换产品安全性的疑虑。此外，需澄清“规格（strength）与效价（potency）”在申报文件中的区别，避免因剂量差异引发安全担忧，并完善药物警戒（pharmacovigilance）体系。 FDA 2024年草案指南若正式落地，将显著降低开发成本与时间，但政策红利能否转化为实际用药收益，仍取决于医保支付方（如药品福利管理机构PBM）的激励政策、医患认知提升与监管可预测性的协同推进。唯有多方合力，可互换生物类似药才能真正成为降低医疗支出的利器。

2025-10-23

·ETPharma

Biocon Biologics gets Canadian regulator nod for immunology biosimilar Yesintek'

Bengaluru: Biocon Biologics announced that its immunology biosimilar brand Yesintek has secured Notice of Compliance from Canada 's drug regulator, Health Canada . Yesintek is a biosimilar brand of Johnson and Johnson's blockbuster biologic Stelara (Ustekinumab), which is indicated for the treatment of several immune-mediated inflammatory diseases, including plaque psoriasis, psoriatic arthritis, Crohn and ulcerative colitis in adults. During its exclusivity phase, Stelara was one of Johnson & Johnson’s leading assets and in 2024 the brand racked up around $10.4 billion in net sales However, the innovator had inked several patent settlements with several drugmakers including, paving the way for its biosimilar entry in the US market. Biocon’s Yesintik is stated to be, “highly similar to Stelara with no clinically meaningful differences in efficacy, safety and immunogenicity. The Indian drugmaker will market the therapy under its patient support program My Biocon Biologics , as prefilled syringes and vials. “Building on our successful U.S. launch, this approval strengthens our presence in North America and enhances our immunology portfolio with a more affordable treatment option for Canadian patients living with chronic autoimmune conditions,” said Shreehas Tambe, CEO and MD, Biocon Biologics. By Online Bureau ,

上市批准专利侵权生物类似药免疫疗法

2025-05-21

·ETPharma

Biocon Biologics debuts its psoriasis biosimilar in Japan

Bengaluru: Biocon Biologics , a subsidiary of Biocon announced that its commercial partner in Japan, Yoshindo Inc. , has launched the psoriasis biosimilar Ustekinumab BS Subcutaneous Injection in the country. The biosimilar is developed and manufactured by Biocon Biologics, and was approved by the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan in December 2024. Ustekinumab, is approved for the treatment of psoriasis vulgaris and psoriatic arthritis (PsA) and will be commercialized and marketed in Japan by Yoshindo Inc. The launched drug is a biosimilar version of blockbuster drug Stelara (ustekinumab) marketed by Janssen Biotech, a subsidiary of US giant Johnson and Johnson and is one of the key sales drives of the company. In 2023, Stelara generated approximately $10.9 billion in net sales across global markets. However, in 2024, sales decreased to around $10.4 billion, reflecting a decline of 4.6 per cent from the previous year figures. The reduction in revenue has been attributed to the introduction of biosimilars in the US drug market. In April 2024, the Indian drugmaker inked a licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) to commercialize Ustekinumab in Japan upon regulatory approval, the release stated. Biocon Biologics has already launched Ustekinumab in the United States and Europe in February 2025 under the brand name ‘Yesintek’. Notably, Japan features among the seven major drug markets in the world and offers a lucrative sales opportunity to drugmakers. Yesintek is a monoclonal antibody that targets two proteins—Interleukin-12 (IL-12) and Interleukin-23 (IL-23)--- to regulate the immune response and control chronic inflammation . As per Biocon, clinical studies showed that Yesintek has similar pharmacokinetic (a key metric to prove similarity with the RBD) safety, efficacy and immunogenicity profile compared with Stelara. By Online Bureau ,

上市批准引进/卖出

100 项与乌司奴单抗生物类似药 (Biocon) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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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
溃疡性结肠炎	加拿大	Biocon Ltd.	2025-10-17
银屑病关节炎	美国	Biocon Biologics, Inc.	2024-11-29
活动性中度克罗恩病	美国	Biocon Biologics, Inc.	2024-11-29
活动性重度克罗恩病	美国	Biocon Biologics, Inc.	2024-11-29
斑块状银屑病	美国	Biocon Biologics, Inc.	2024-11-29
活动性中度溃疡性结肠炎	美国	Biocon Biologics, Inc.	2024-11-29
活动性重度溃疡性结肠炎	美国	Biocon Biologics, Inc.	2024-11-29

未上市

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适应症	最高研发状态	国家/地区	公司	日期
克罗恩病	临床1期	英国	Biocon Ltd.	2022-04-19

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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


NCT05335356 (STELLAR-2, Pubmed \| Expert Opin Biol Ther)	临床3期	斑块状银屑病	324	Bmab 1200	衊襯餘壓窪憲醖築襯淵(願廠鬱夢糧餘鏇鹽網範) = 網衊鏇衊遞衊窪遞餘製醖鬱壓夢願積壓鏇網夢 (糧廠膚範顧艱顧襯衊鑰, 7.51) 更多	积极	2025-10-21
				Reference Ustekinumab	衊襯餘壓窪憲醖築襯淵(願廠鬱夢糧餘鏇鹽網範) = 製製夢構範蓋膚鏇築糧醖鬱壓夢願積壓鏇網夢 (糧廠膚範顧艱顧襯衊鑰, 5.67) 更多
NCT05335356 (STELLAR-2, Pubmed \| Expert Opin Biol Ther)	临床3期	斑块状银屑病	384	Bmab 1200	顧製淵窪觸願窪壓顧廠(觸製襯選鹽衊願窪壓顧): Difference (%) = 0.68 (90.0% CI, -1.27 ~ 2.63) 更多	积极	2025-08-03
				Reference Ustekinumab
NCT05335356 (STELLAR-2, EADV2024) 人工标引	临床3期	斑块状银屑病	384	Bmab1200	淵簾構遞範積鏇築網繭(膚範繭鏇鑰窪築衊齋製) = 壓選構醖顧衊選夢壓簾製膚願製願膚壓憲構艱 (選窪簾積糧廠鬱壓鏇醖, -85.40 ~ -74.35)	非劣	2024-09-25
				Ustekinumab	淵簾構遞範積鏇築網繭(膚範繭鏇鑰窪築衊齋製) = 膚窪鹹網壓遞鑰顧製齋製膚願製願膚壓憲構艱 (選窪簾積糧廠鬱壓鏇醖, -86.01 ~ -75.10)