BAT2306 (secukinumab biosimilar) / Bio-Thera Solutions, Jamjoom Pharmaceuticals - LARVOL DELTA

A Multicenter, Randomized, Double-Blind, Parallel-Arm, Phase 3 Study to Compare Efficacy and Safety of BAT2306 with Secukinumab in Patients with Moderate to Severe Plaque Psoriasis (EADV 2025) - "The current study showed that BAT2306 and Secukinumab are similar in terms of efficacy, safety, PK, and immunogenicity. Additionally, the transition from Secukinumab to BAT2306 in TP2 had no impact on efficacy, safety, PK, or immunogenicity."

Clinical • P3 data • Dermatology • Immunology • Psoriasis • IL17A

Jamjoom Pharma partners with Bio-Thera to secure Cosentyx biosimilar in MENA (Zawya) - "Under the partnership, the Saudi-listed group will have the exclusive rights to commercialize BAT2306 - a proposed biosimilar to Novartis’ Cosentyx (secukinumab), across the MENA region...Jamjoom Pharma will handle regulatory submissions, market access, and commercialization in MENA."

Commercial • Immunology

FIFTY-TWO-WEEK RESULTS FROM A PHASE 3, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED CLINICAL TRIAL TO COMPARE BAT2306, A PROPOSED SECUKINUMAB BIOSIMILAR, WITH A SECUKINUMAB REFERENCE PRODUCT IN SUBJECTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS (EULAR 2025) - "The current study showed that BAT2306 and SEC are similar in terms of efficacy, safety, PK, and immunogenicity in TP1."

Clinical • P3 data • Dermatology • Immunology • Psoriasis

Assessment on Efficacy and Safety of BAT2306 and Cosentyx® in Plaque Psoriasis Patients (clinicaltrials.gov) - P3 | N=502 | Completed | Sponsor: Bio-Thera Solutions | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Bio-Thera Announces that the National Medical Products Administration has accepted the marketing application for BAT2306, a biosimilar developed based on Cosentyx (secukinumab) [Google translation] (Biothera Press Release) - "The company announced today that the marketing authorization application for BAT2306 , a biosimilar developed based on Cosentyx (secukinumab), has been accepted by the National Medical Products Administration."

China filing • Psoriasis

Comparative Study to Evaluate the Pharmacokinetics of BAT2306 vs Cosentyx® in Healthy Subjects (clinicaltrials.gov) - P1 | N=216 | Completed | Sponsor: Bio-Thera Solutions | Active, not recruiting ➔ Completed | Trial completion date: Sep 2023 ➔ Jun 2023

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

Assessment on Efficacy and Safety of BAT2306 and Cosentyx® in Plaque Psoriasis Patients (clinicaltrials.gov) - P3 | N=502 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Trial primary completion date: Aug 2023 ➔ Jul 2024

Trial primary completion date • Dermatology • Immunology • Psoriasis

Comparative Study to Evaluate the Pharmacokinetics of BAT2306 vs Cosentyx® in Healthy Subjects (clinicaltrials.gov) - P1 | N=216 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Trial completion date: May 2023 ➔ Sep 2023

Trial completion date • Dermatology • Immunology • Psoriasis

Assessment on Efficacy and Safety of BAT2306 and Cosentyx® in Plaque Psoriasis Patients (clinicaltrials.gov) - P3 | N=502 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2023 ➔ Aug 2023

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

Hope for Biologic Treatment of Hidradenitis Suppurativa (RheumNow) - "A meta-analysis of trials using biologics [adalimumab (ADA), ustekinumab (UST) and secukinumab (SEC)] in the the management of hidradenitis suppurativa (HS) suggests promising results, but more controlled, rigorous studies are needed....Ribero et a: retrospective study of 31 HS patients treated with SEC - the HiSCR was achieved by 41% of patients at week 28. No adverse events."

Online posting

Comparative Study to Evaluate the Pharmacokinetics of BAT2306 vs Cosentyx® in Healthy Subjects (clinicaltrials.gov) - P1 | N=216 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Dec 2022 ➔ May 2023 | Trial primary completion date: Sep 2022 ➔ May 2023

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

Assessment on Efficacy and Safety of BAT2306 and Cosentyx® in Plaque Psoriasis Patients (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Bio-Thera Solutions | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

Treatment Improves Patient-Reported Outcomes in Adults With Psoriatic Arthritis (HMP Global) - '"These results indicate that secukinumab provides comprehensive improvement for patients with psoriatic arthritis, regardless of previous therapy,' wrote lead and corresponding author Vibeke Strand, MD..."

Media quote

Assessment on Efficacy and Safety of BAT2306 and Cosentyx® in Plaque Psoriasis Patients (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: Bio-Thera Solutions

New P3 trial • Dermatology • Immunology • Psoriasis

Comparative Study to Evaluate the Pharmacokinetics of BAT2306 vs Cosentyx® in Healthy Subjects (clinicaltrials.gov) - P1; N=216; Not yet recruiting; Sponsor: Bio-Thera Solutions

Clinical • New P1 trial • Dermatology • Immunology • Psoriasis