Yesintek (ustekinumab-kfce) / Biocon, Yoshindo - LARVOL DELTA

From anti-drug antibody incidence to clinical relevance: interpreting highly sensitive immunogenicity assays in biosimilars. (PubMed, Bioanalysis) - P3 | "Biosimilar immunogenicity testing is a confirmatory exercise against an already-approved reference, not an investigative characterization. As regulatory frameworks move toward reduced reliance on comparative Phase 3 studies, identifying persistent ADA responses at Phase 1 becomes increasingly important; a fit-for-purpose, comparability-anchored analytical strategy warrants collective regulatory rethinking.Clinical trial registration: www.isrctn.com; identifier: ISRCTN1142400EudraCT Number: 2021-006668-25;ClinicalTrials.gov: NCT05335356 ClinicalTrials.gov: NCT05323708EudraCT number: 2021-006545-36, CT.gov number: NCT05345691."

Journal

Biocon Limited announced on August 18, 2026, that its U.S. subsidiary received supplemental approval from the Food and Drug Administration (FDA) for Yesintek (ustekinumab-kfce) single-dose prefilled autoinjectors (Scanx) - "The regulatory nod covers two dosage strengths: 45 mg/0.5 ml and 90 mg/ml."

FDA approval • Crohn's disease • Plaque Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Biocon Ltd on Wednesday said it has received notice of compliance approval from Canadian health regulator for its Yesintek (ustekinumab) autoinjector, indicated for the treatment of moderate to severe plaque psoriasis (Business Standard) - "The company's subsidiary in Canada has received Notice of Compliance (NOC) approval for Yesintek (ustekinumab) Autoinjector 45 mg/0.05 mL and 90 mg/mL from Health Canada, Biocon Ltd said in a regulatory filing. Health Canada previously granted NOC for Yesintek (solution for subcutaneous injection) 45 mg/0.5ml (prefilled syringe and vial) and 90 mg/ml (prefilled syringe) and Yesintek I.V. (solution for intravenous infusion) 130 mg/26 mL (5mg/mL) in October 2025, it added....The new format will allow customised treatment approaches across care settings and patient needs, it added."

Canada approval • Plaque Psoriasis

Human factors validation study of a disposable autoinjector (Bmab 1200 autoinjector) for subcutaneous delivery of Ustekinumab. (PubMed, Drug Deliv) - "All participants expressed confidence in safe dosing and found the device user-friendly. The Bmab 1200 autoinjector demonstrated high usability and safety across diverse users for ustekinumab biosimilar delivery in chronic autoimmune conditions."

Journal • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis

CVS Caremark to remove Stelara from commercial formularies (Managed Healthcare Executive) - "Beginning July 1, 2026, CVS Caremark will transition from Stelara (ustekinumab) on its most common commercial template formularies to preferring the interchangeable biosimilars Pyzchiva and Yesintek. Most members will pay $0 out-of-pocket....Stelara and its biosimilars treat patients with psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis."

Commercial • Crohn's disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Efficacy and safety of ustekinumab biosimilars for treating moderate-to-severe plaque psoriasis: a systematic review and network meta-analysis. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "2) For the dermatology life quality index, Bmab1200, AVT04 and CT-P43, had statistically significant differences from the RLD (P < 0.05)...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."

Journal • Retrospective data • Review • Dermatology • Immunology • Psoriasis

Comparative pharmacokinetics of ustekinumab biosimilar administered via autoinjector or prefilled syringe in healthy subjects (AAD 2026) - "The safety and tolerability profiles were similar between the treatment arms. This study demonstrated PK equivalence as well as similar safety and tolerability of Bmab 1200 administered via AI or PFS in healthy subjects."

Clinical • PK/PD data

Biocon said that Health Canada has granted a notice of compliance (NOC) for Yesintek and Yesintek I.V. to Biocon Biologics. (Business Standard) - "The Health Canada approval was based on a comprehensive data package, confirming that YESINTEK is highly similar to Stelara with no clinically meaningful differences in efficacy, safety and immunogenicity."

Canada approval • Crohn's disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

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. (PubMed, Expert Opin Biol Ther) - P3 | "Long-term comparable efficacy and safety were also maintained. www.clinicaltrials.gov identifier is NCT05335356 and www.clinicaltrialsregister.eu identifier is 2021-006668-25."

Journal • P3 data • Dermatology • Immunology • Psoriasis

This is Comparative 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). (clinicaltrials.gov) - P1 | N=186 | Completed | Sponsor: Biocon Biologics UK Ltd | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

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. (PubMed, Expert Opin Biol Ther) - P3 | "Bmab 1200 and reference ustekinumab had similar efficacy, safety, immunogenicity, and PK in patients with moderate-to-severe plaque psoriasis. www.clinicaltrialsregister.eu identifier is 2021 -006,668-25; www.clinicaltrials.gov identifier is NCT05335356."

Clinical • Journal • P3 data • Dermatology • Immunology • Psoriasis

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2025 (European Medicines Agency) - "On 24 July 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Usrenty, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease....Usrenty is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A)."

CHMP • Crohn's disease • Psoriasis • Psoriatic Arthritis

This is Comparative 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). (clinicaltrials.gov) - P1 | N=186 | Active, not recruiting | Sponsor: Biocon Biologics UK Ltd | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Jan 2026 ➔ Jul 2025 | Trial primary completion date: Jan 2026 ➔ Jul 2025

Enrollment closed • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

Biocon Biologics receives UK MHRA approval for YESINTEK, Biosimilar Ustekinumab (Business Upturn) - "Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd., has announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for YESINTEK, a biosimilar of Ustekinumab. YESINTEK is approved for use in adults and children aged 6 years and older with moderate to severe plaque psoriasis. It is also indicated for adults with active psoriatic arthritis and moderately to severely active Crohn’s disease....The MHRA authorisation enables the marketing of YESINTEK in the United Kingdom."

MHRA approval • Psoriasis

Biocon Biologics and Yoshindo Inc. launch Ustekinumab Biosimilar in Japan (Business Standard) - "Biocon Biologics, subsidiary of Biocon, announced today that its commercial partner in Japan, Yoshindo Inc., has launched Ustekinumab BS Subcutaneous Injection [YD], a biosimilar to the reference product Stelara (ustekinumab). The biosimilar ustekinumab, developed and manufactured by Biocon Biologics, is commercialized and marketed in Japan by Yoshindo Inc. Ustekinumab, a monoclonal antibody, is approved for the treatment of psoriasis vulgaris and psoriatic arthritis (PsA)."

Biosimilar launch • Immunology • Psoriasis • Psoriatic Arthritis

Biocon shares rise after subsidiary launches psoriasis treatment drug in Japan (CNBC-TV18) - "Shares of Biocon Ltd. gained as much as 2% on Wednesday, May 21, after its subsidiary announced that its commercial partner in Japan launched the Ustekinumab BS Subcutaneous injection for the treatment of psoriasis vulgaris and psoriatic arthritis....Four biosimilars of Biocon crossed the sales mark of $200 million each during financial year 2025. Biocon shares gained 2% to hit an intraday high of ₹339.5 apiece. The stock has declined 8.3% this year, so far."

Commercial • Sales • Immunology • Psoriasis • Psoriatic Arthritis

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). (PubMed, Expert Opin Investig Drugs) - "Diversity limited to white and Japanese groups did not impact the study results. This study was registered with www.isrctn.com identifier is (ISRCTN11424009)."

Clinical • Journal • PK/PD data

Biocon secures multiple market access agreements for Yesintek (CNBC-TV18) - "Biocon Ltd. on Monday, May 5, said its subsidiary Biocon Biologics has secured multiple market access agreements for Yesintek, its biosimilar to Stelara....Express Scripts has added Yesintek to the National Preferred Formulary (NPF) effective March 21, 2025. Cigna has added Yesintek to its commercial formulary beginning on March 21, 2025. United Healthcare has added Yesintek to several formularies including commercial beginning May 1, 2025; managed Medicaid beginning March 1, 2025; and Medicare beginning June 1, 2025. CVS Health has added Yesintek beginning July 1, 2025. And finally, Optum Rx has added Yesintek to its Premium and Select formularies beginning July 1, 2025."

Reimbursement • Crohn's disease • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Ulcerative Colitis

Randomized, double-blind, parallel group, multicenter, Phase 3 study to demonstrate equivalent efficacy and to assess safety, immunogenicity and pharmacokinetics of BMAb-1200 compared to reference ustekinumab in adult subjects with moderate to severe chronic plaque psoriasis (AAD 2025) - "This study demonstrated equivalent efficacy and similar safety, immunogenicity as well as PK between Bmab-1200 and ustekinumab."

Clinical • P3 data • PK/PD data • Dermatology • Immunology • Psoriasis

Biocon Biologics Announces Positive Results from Phase 3 Study of Yesintek Biosimilar to Ustekinumab for Chronic Plaque Psoriasis (PRNewswire) - P3 | N=384 | STELLAR-2 (NCT05335356) | Sponsor: Biocon Biologics UK Ltd | "The data are being presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida...The primary efficacy endpoint, percentage change from baseline in Psoriasis Area and Severity Index (PASI) score at Week 12, demonstrated that YESINTEK was equivalent to reference Stelara (Ustekinumab), with both treatments showing similar improvement in PASI scores. The mean difference between the two groups was 0.68%, falling within the predefined equivalence margins for both the U.S. Food and Drug Administration (U.S. FDA) and European Medicines Agency (EMA)...The pharmacokinetic and immunogenicity profiles of YESINTEK were found to be similar to those of reference Stelara (Ustekinumab), with no significant differences in efficacy or safety outcomes between the two treatments."

P3 data • Immunology • Psoriasis

MedImpact Expands Access to Two Biosimilars for Stelara (Businesswire) - "MedImpact Healthcare Systems, the nation’s largest independent provider of health solutions, technology, and pharmacy benefit management services, announced that it is expanding access to two biosimilar alternatives to Stelara (ustekinumab), Selarsdi (ustekinumab-aekn) and Yesintek (ustekinumab-kfce). Consistent with its mission of delivering affordability without compromising access, MedImpact’s approach to biosimilars is pharmacy- and manufacturer-neutral."

Reimbursement • Immunology • Inflammation

Biocon Biologics Launches Yesintek (ustekinumab-kfce) Biosimilar to Stelara in the United States (PRNewswire) - "Biocon Biologics Ltd...today announced that YESINTEK (ustekinumab-kfce) is now available to patients in the United States, and is one of the first Stelara (ustekinumab) biosimilar market entrants in the country. YESINTEK is approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, increasing patient access to more cost-effective treatment options for use in the treatment of common chronic autoimmune diseases."

Biosimilar launch • Crohn's disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

European Commission Approves Biocon Biologics’ Ustekinumab Biosimilar (Biocon Press Release) - "Biocon Biologics Ltd (BBL)...announced today that the European Commission (EC) granted marketing authorisation in the European Union (EU) for YESINTEK, a biosimilar of Ustekinumab....YESINTEK, is intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease."

EMA approval • Crohn's disease • Psoriasis • Psoriatic Arthritis

This is Comparative 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). (clinicaltrials.gov) - P1 | N=186 | Not yet recruiting | Sponsor: Biocon Biologics UK Ltd

New P1 trial • Dermatology • Immunology • Psoriasis

Yesintek (European Medicines Agency) - "...the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Yesintek, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease."

CHMP • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis