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

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

Biocon Biologics gets US nod to launch Stelara biosimilar (The Economic Times) - "Biocon Biologics, the subsidiary of Biocon on Saturday has received the USFDA nod to launch the biosimilar version of Janssen's Stelara (Ustekinumab) used for the treatment of autoimmune disorders such as Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. Biocon Biologics will be able to launch the drug in the US no later than on February 22, 2025, as per the settlement and licensing agreement with Janssen....The U.S. FDA has accepted the company’s Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway."

Biosimilar launch • FDA approval • Immunology • Psoriasis

A Randomized, Double-blind, Parallel Group, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Bmab 1200 and Reference Biologic-Ustekinumab in Patients with Moderate to Severe Chronic Plaque Psoriasis 28-week Results (EADV 2024) - "This study established equivalent efficacy and comparable safety of Bmab 1200 with ustekinumab in patients with moderate to severe chronic plaque Pso. Table 1. Percentage Change from Baseline in Psoriasis Area and Severity Index Score at Week 12 (Full Analysis Set) Bmab 1200 (N=191) Ustekinumab (N=193) Difference between Treatments Primary estimand n 191 193 - LSM (SE) -79.87 (2.818) -80.55 (2.783) - 95% CI -85.40, -74.35 -86.01, -75.10 - LSM - - 0.6800 90% CI - - -1.27, 2.63 95% CI - - -1.64, 3.00 Secondary estimand n 191 193 - LSM (SE) -80.15 (2.841) -80.76 (2.801) - 95% CI -85.72, -74.58 -86.25, -75.27 - LSM difference - - 0.6067 90% CI - - -1.36, 2.57 95% CI - - -1.73, 2.95 CI, confidence interval; LSM, least squares mean; N, Total number of patients; n, patients with available data; SE, standard error"

Clinical • P3 data • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis • IL23A

Biocon Biologics Announces New Dermatology Data to Be Presented at EADV Congress 2024 (Canada Newswire) - P3 | N=384 | STELLAR-2 (NCT05335356) | Sponsor: Biocon Biologics UK Ltd | "A total of 384 patients were evaluated for 52 weeks and the primary efficacy endpoint was percentage change from baseline (%CFB) in PASI at Week 12. In the primary efficacy analysis at 28 weeks, Bmab 1200 and ustekinumab were equivalent and the data support biosimilarity. The study established equivalent efficacy and comparable safety of Bmab 1200 with ustekinumab in patients with moderate to severe chronic plaque Pso."

P3 data • Dermatology • Immunology • Psoriasis

Biocon Biologics Secures Market Entry for Bmab 1200, a Proposed Biosimilar to Stelara, in Europe, UK, Canada, and Japan (PRNewswire) - "Biocon Biologics...announced today that the Company has signed a settlement and license agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) that clears the way to commercialize its Bmab 1200, a proposed biosimilar to Stelara, in Europe, the United Kingdom (UK), Canada, and Japan....Biocon Biologics earlier announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025, once approved by the U.S. FDA."

Biosimilar launch • Licensing / partnership • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis

STELLAR-2: Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - P3 | N=384 | Completed | Sponsor: Biocon Biologics UK Ltd | Active, not recruiting ➔ Completed | Trial completion date: May 2024 ➔ Nov 2023

Trial completion • Trial completion date • Dermatology • Immunology • Psoriasis

Biocon Biologics Secures US Market Entry Date for Bmab 1200, a Proposed Biosimilar to Stelara (Biocon Press Release) - "Biocon Biologics Ltd...announced today that the Company has signed a settlement and license agreement with Janssen Biotech Inc., and Johnson & Johnson (collectively known as Janssen) that clears the way to commercialize its Bmab 1200, a proposed biosimilar to Stelara, in the United States of America....The agreement licenses the Company to launch in the United States, in February 2025, once approved by the U.S. FDA. The U.S. FDA has accepted the Company’s Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway."

Biosimilar launch • Licensing / partnership • Immunology • Psoriasis

STELLAR-2: Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - P3 | N=384 | Active, not recruiting | Sponsor: Biocon Biologics UK Ltd | Trial completion date: Oct 2023 ➔ May 2024

Trial completion date • Dermatology • Immunology • Psoriasis

STELLAR-2: Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - P3 | N=384 | Active, not recruiting | Sponsor: Biocon Biologics UK Ltd | Trial primary completion date: Jul 2023 ➔ Jan 2023

Trial primary completion date • Dermatology • Immunology • Psoriasis

STELLAR-2: Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - P3 | N=384 | Active, not recruiting | Sponsor: Biocon Biologics UK Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Psoriasis

Biocon in pact with Japan’s Yoshindo to commercialise two biosimilar assets (Livemint) - "Biocon Biologics has entered into a strategic out-licensing agreement with Japanese pharmaceuticals company, Yoshindo Inc., for commercialising Ustekinumab and Denosumab, two of its biosimilar assets in the pipeline, in the Japanese market. As part of the agreement, Yoshindo will get exclusive commercialisation rights in Japan for bUstekinumab and bDenosumab, developed and manufactured by Biocon Biologics, for an addressable market opportunity of over $700 million."

Licensing / partnership • Immunology • Psoriasis

STELLAR-2: Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - P3 | N=384 | Recruiting | Sponsor: Biocon Biologics UK Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis