Omazijev (omalizumab biosimilar) / Aurobindo, CuraTeQ Biologics - LARVOL DELTA

Aurobindo Pharma’s CuraTeQ Biologics announces positive results for omalizumab biosimilar study (Business Upturn) - "The study, which involved 608 patients across approximately 80 sites in seven European countries and India, successfully met all primary endpoints. It demonstrated high comparability to the reference product in patients with chronic spontaneous urticaria (CSU) at the 300 mg dose....The results showed precise equivalence, with tight confidence intervals well within the predefined margins of -2.5 to 2.0. The co-primary endpoint of relative potency, based on change from baseline in ISS7 at Week 12 using a 4-point assay, also met its criteria, demonstrating parallelism between BP11 and Xolair across dose levels."

P3 data • Chronic Spontaneous Urticaria

Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of BP11 (Omalizumab Biosimilar) Compared To EU-Omalizumab And US-Omalizumab (AAAAI 2026) - "Conclusions This study demonstrates PK similarity among three products. The pharmacodynamic, safety and immunogenicity profiles observed for the three products in this study are consistent with previous Omalizumab reports."

Clinical • PK/PD data • Infectious Disease • Respiratory Diseases

Aurobindo arm CuraTeQ successfully wraps up Ph-1 trial for Omalizumab biosimilar (The Times of India) - P1 | N=165 | NCT05053334 | Sponsor: Syneos Health | "Aurobindo Pharma Ltd on Friday informed the bourses that its wholly owned subsidiary, CuraTeQ Biologics Pvt Ltd’s Omalizumab biosimilar candidate – BP11 – has met the Phase-1 trial end points as compared to the US and EU sourced reference product Xolair. Omalizumab is a monoclonal antibody used for the treatment of asthma and hives. Aurobindo said CuraTeQ intends to take up two Phase-3 studies across Europe and India and plans to seek regulatory approval for the Omalizumab biosimilar product in India in 2024 and in regulated markets in 2025....Results of both primary parameters, which is the maximum serum concentration (Cmax) and area under concentration-time curve from time zero to infinity (AUC0-inf), were contained within 80-125% bioequivalence limit demonstrating PK equivalence between BP11 and both US and EU sourced Xolair..."

Non-US regulatory • P2 data • Regulatory • Asthma

Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair (clinicaltrials.gov) - P1 | N=165 | Completed | Sponsor: Syneos Health | Active, not recruiting ➔ Completed

Trial completion

Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair (clinicaltrials.gov) - P1 | N=165 | Active, not recruiting | Sponsor: Syneos Health | Recruiting ➔ Active, not recruiting

Enrollment closed

Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair (clinicaltrials.gov) - P1 | N=165 | Recruiting | Sponsor: Syneos Health | Trial completion date: May 2023 ➔ Oct 2023 | Trial primary completion date: Apr 2023 ➔ Oct 2023

Trial completion date • Trial primary completion date

BP11 Versus EU-Approved Xolair® in Patients With Chronic Spontaneous Urticaria (clinicaltrialsregister.eu) - P3 | N=600 | Ongoing | Sponsor: CuraTeQ Biologics Private Ltd.

New P3 trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Rheumatology • Urticaria

Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair (clinicaltrials.gov) - P1 | N=165 | Recruiting | Sponsor: Syneos Health | Trial completion date: Oct 2022 ➔ May 2023 | Trial primary completion date: Oct 2022 ➔ Apr 2023

Trial completion date • Trial primary completion date