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Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

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

+ [2]

Target

IL-12p40 x IL-23

Action

inhibitors

Mechanism

IL-12p40 inhibitors(Interleukin-12 subunit beta inhibitors), IL-23 inhibitors(Interleukin-23 inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesDigestive System Disorders+ [1]

Active Indication

Arthritis, PsoriaticCrohn's disease, active moderateCrohn's disease, active severe+ [4]

Inactive Indication-

Originator Organization

Biocon Ltd.

Active Organization

Biocon Biologics Ireland Ltd.

Biocon Ltd.Biocon Biologics, Inc.

+ [1]

Inactive Organization-

License Organization

Yoshindo, Inc.

Biocon Biologics Ltd. (India)

Drug Highest PhaseApproved

First Approval Date

United States (29 Nov 2024),

Arthritis, PsoriaticCrohn's disease, active moderateCrohn's disease, active severe+ [3]

Regulation-

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Structure/Sequence

Sequence Code 143665H

The sequence is quoted from: *****

Sequence Code 143874L

The sequence is quoted from: *****

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).

Start Date09 Jan 2025

Sponsor / Collaborator

Biocon Ltd.

CTRI/2024/12/077726

/ Not yet recruitingPhase 1

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

Start Date15 Dec 2024

Sponsor / Collaborator

Biocon Biologics Ltd. (India)

NCT05335356

/ CompletedPhase 3

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.

Start Date28 Jun 2022

Sponsor / Collaborator

Biocon Ltd.

100 Clinical Results associated with Ustekinumab-kfce

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100 Translational Medicine associated with Ustekinumab-kfce

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100 Patents (Medical) associated with Ustekinumab-kfce

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3

Literatures (Medical) associated with Ustekinumab-kfce

29 Jul 2025·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

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

03 Apr 2025·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

Author: Ackroyd, Jonathan ; Kumar, Kuldeep ; 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.

01 Nov 2011·mAbsQ2 · MEDICINE

Discovery and mechanism of ustekinumab

Q2 · MEDICINE

Review

Author: Jill M. Giles-Komar ; David Peritt ; Jacqueline M. Benson ; Mary Ann Mascelli ; George A. Heavner ; David J. Shealy ; Bernard J. Scallon

Monoclonal antibody (mAb) therapy was first established upon the approval of a mouse antibody for treatment of human acute organ rejection. However, the high incidence of immune response against the mouse mAb restricted therapeutic utility. Development of chimeric, "humanized" and human mAbs broadened therapeutic application to immune-mediated diseases requiring long-term treatment. Indeed, mAb therapeutics targeting soluble cytokines are highly effective in numerous immune-mediated disorders. A recent example is ustekinumab, a first-in-class therapeutic human immunoglobulin G1 kappa mAb that binds to the interleukins (IL)-12 and IL-23, cytokines that modulate lymphocyte function, including T-helper (Th) 1 and Th17 cell subsets. Ustekinumab was generated via recombinant human IL-12 immunization of human immunoglobulin (hu-Ig) transgenic mice. Ustekinumab binds to the p40 subunit common to IL-12 and IL-23 and prevents their interaction with the IL-12 receptor β1 subunit of the IL-12 and IL-23 receptor complexes. Ustekinumab is approved for treatment of moderate-to-severe plaque psoriasis and has demonstrated efficacy in Crohn disease and psoriatic arthritis. The clinical characterization of ustekinumab continues to clarify our understanding of human immune pathologies and may offer a novel therapeutic option for certain immune-mediated diseases.

25

News (Medical) associated with Ustekinumab-kfce

21 May 2025

·pharma.economictimes.indiatimes.com

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 ,

Drug ApprovalLicense out/in

21 May 2025

·pharma.economictimes.indiatimes.com

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 ,

Drug ApprovalLicense out/in

15 May 2025

·www.echemi.com

Biocon Announces $150 Million Investment in Biologics and Generics Over Two Years

On May 11, 2025, Biocon, a leading biopharmaceutical company, revealed plans to invest $150 million in capital expenditure (capex) over the next two years. The investment includes $100 million for its biologics division, with a significant portion allocated to expanding manufacturing capacity in Malaysia, and $50 million for generics. Biocon’s CEO, Siddharth Mittal, confirmed that the generics capex program will largely conclude next year, leaving only minimal maintenance spending thereafter. Meanwhile, Biocon’s biologics capex will moderate after this expansion phase. The announcement followed Biocon’s Q4 earnings report, which showed a 153% surge in net profit to ₹344 crore and a 12% increase in consolidated revenue to ₹4,454 crore. Key drivers included biosimilars, generics growth, and strong demand in research services. Biocon recently launched lenalidomide and dasatinib in the US, along with liraglutide in the UK, bolstering its oncology and diabetes portfolios. The company is eyeing the launch of bevacizumab in the US later this year, alongside anticipated approval for insulin aspart. With four biosimilars each generating $200 million in FY25 sales, Biocon is strengthening its foothold in global markets. It also launched ustekinumab, a biosimilar to Stelara, in the US and expanded its biologics manufacturing footprint through a facility acquisition. To support its growth plans, Biocon is raising ₹4,500 crore via QIP and private placements, aimed at meeting financial obligations and funding biologics investments.

AcquisitionBiosimilarFinancial StatementDrug Approval

100 Deals associated with Ustekinumab-kfce

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L04AC05	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Arthritis, Psoriatic	United States	Biocon Biologics, Inc.	29 Nov 2024
Crohn's disease, active moderate	United States	Biocon Biologics, Inc.	29 Nov 2024
Crohn's disease, active severe	United States	Biocon Biologics, Inc.	29 Nov 2024
Plaque psoriasis	United States	Biocon Biologics, Inc.	29 Nov 2024
Ulcerative colitis, active moderate	United States	Biocon Biologics, Inc.	29 Nov 2024
Ulcerative colitis, active severe	United States	Biocon Biologics, Inc.	29 Nov 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic large plaque psoriasis	Phase 3	United States	Biocon Ltd.	28 Jun 2022
Crohn Disease	Phase 1	United Kingdom	Biocon Ltd.	19 Apr 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05335356 (STELLAR-2, EADV2024) Manual	Phase 3	Plaque psoriasis	384	Bmab1200	lersjdhzey(nfevmwnkkb) = bgpkamwngo lwvgfzrlvu (amaffhrbzx, -85.40 to -74.35)	Non-inferior	25 Sep 2024
				Ustekinumab	lersjdhzey(nfevmwnkkb) = orztoveney lwvgfzrlvu (amaffhrbzx, -86.01 to -75.10)

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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Ustekinumab-kfce

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation