乌司奴单抗生物类似药 (Biocon)(Ustekinumab-kfce) - 药物靶点：IL-12p40_在研适应症：溃疡性结肠炎，银屑病关节炎，活动性中度克罗恩病_专利_临床

概要

基本信息

药物类型

生物类似药、单克隆抗体

别名

Ustekinumab Biosimilar (Biocon Ltd.)、乌司奴单抗生物类似药（Biocon Ltd.）、BMAB 1200

+ [2]

靶点

IL-12p40

作用方式

抑制剂

作用机制

IL-12p40抑制剂(白细胞介素-12β亚基抑制剂)

治疗领域

免疫系统疾病感染消化系统疾病+ [1]

在研适应症

溃疡性结肠炎银屑病关节炎活动性中度克罗恩病+ [4]

非在研适应症-

原研机构

Biocon Ltd.

在研机构

Biocon Biologics Ireland Ltd.

Yoshindo, Inc.

Biocon Ltd.

+ [1]

非在研机构-

权益机构

Yoshindo, Inc.

Biocon Biologics Ltd. (India)

最高研发阶段批准上市

首次获批日期

美国 (2024-11-29),

银屑病关节炎活动性中度克罗恩病活动性重度克罗恩病+ [3]

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 143665H

当前序列信息引自: *****

Sequence Code 143874L

当前序列信息引自: *****

关联

4

项与乌司奴单抗生物类似药 (Biocon) 相关的临床试验

NCT06738277

/ Completed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)

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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4

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. ; Athalye, Sandeep N. ; Marwah, Ashwani ; 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 ; Wolff-Holz, Elena ; Marwah, Ashwani ; 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.

27

项与乌司奴单抗生物类似药 (Biocon) 相关的新闻（医药）

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

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
-	-	L04AC05	-

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

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
克罗恩病	临床1期	英国	Biocon Ltd.	2022-04-19

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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


NCT05335356 (STELLAR-2, Pubmed \| Expert Opin Biol Ther)	临床3期	斑块状银屑病	324	Bmab 1200	構簾製鹽淵鏇糧構築構(夢夢壓艱築蓋鹹獵製範) = 壓鏇廠衊齋鬱憲壓膚鑰襯鹽艱淵積蓋鏇淵鹽鬱 (繭壓網鹽鹽憲網選憲壓, 7.51) 更多	积极	2025-10-21
				Reference Ustekinumab	構簾製鹽淵鏇糧構築構(夢夢壓艱築蓋鹹獵製範) = 醖顧製醖蓋艱網鹽遞獵襯鹽艱淵積蓋鏇淵鹽鬱 (繭壓網鹽鹽憲網選憲壓, 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	構廠製範鑰鹽網淵艱鏇(淵範餘膚鏇窪壓簾觸艱): 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	構齋衊網製築憲顧憲衊(淵襯襯網鹽膚構構蓋餘) = 夢廠蓋構積獵觸艱廠獵夢網製淵鬱築選鑰遞淵 (鏇願醖網築簾廠鑰膚簾, -85.40 ~ -74.35)	非劣	2024-09-25
				Ustekinumab	構齋衊網製築憲顧憲衊(淵襯襯網鹽膚構構蓋餘) = 築餘範艱鏇鬱壓夢齋觸夢網製淵鬱築選鑰遞淵 (鏇願醖網築簾廠鑰膚簾, -86.01 ~ -75.10)