Handayuan (adalimumab biosimilar) / Fosun Pharma, Getz Pharma - LARVOL DELTA

Study of Efficacy and Safety of HLX03 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=262 | Completed | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Efficacy and Safety of HLX03, an Adalimumab Biosimilar, in Patients with Moderate-to-Severe Plaque Psoriasis: A Randomized, Double-Blind, Phase III Study. (PubMed, Adv Ther) - P3 | "HLX03 demonstrated equivalent efficacy, similar safety and immunogenicity to reference adalimumab, supporting its development as an alternative treatment for patients with plaque psoriasis in China."

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

Pharmacokinetics, safety, and immunogenicity of HLX03, an adalimumab biosimilar, compared with reference biologic in healthy Chinese male volunteers: Results of a randomized, double-blind, parallel-controlled, phase 1 study. (PubMed, Pharmacol Res Perspect) - "This study demonstrated PK bioequivalence between HLX03 and CN-adalimumab, with similar safety and immunogenicity profiles. These data support further clinical development of HLX03 as an adalimumab biosimilar."

Clinical • Journal • P1 data • PK/PD data

Phase I Study of HLX3 vs Adalimumab in Chinese Healthy Subjects (clinicaltrials.gov) - P1; N=220; Completed; Sponsor: Shanghai Henlius Biotech; Active, not recruiting ➔ Completed; N=148 ➔ 220

Clinical • Enrollment change • Trial completion

[VIRTUAL] Efficacy, Safety and Immunogenicity of the Biosimilar HLX03 Compared with Adalimumab in Chinese Patients with Moderate to Severe Plaque Psoriasis: a Randomised; Double-blind; Phase 3 Equivalence Study (EADV 2020) - No abstract available

Clinical • P3 data • Dermatology • Immunology • Psoriasis

Quality by Design-Based Assessment for Analytical Similarity of Adalimumab Biosimilar HLX03 to Humira®. (PubMed, AAPS J) - "Finally, a panel of advanced and orthogonal physicochemical and functional tests and comparison of 6 batches of HLX03 and 10 batches of the reference standard demonstrated high similarity of HLX03 to Humira®, except for slightly lower percentage of high mannosylated glycans (%HM) in HLX03 which had no effect on FcγRIII binding and antibody-dependent cell-mediated cytotoxicity (ADCC) activity in human peripheral blood mononuclear cell (PBMC). All above demonstrated the feasibility and efficiency of QbD-based similarity assessment of a biosimilar monoclonal antibody (mAb)."

Journal

Fu Hong Hanlin (02696) Liu Shigao: HLX03 and HLX02 are expected to be listed in 2020 [Google translation] (Eastmoney.com) - "HLX03 (adalimumab injection) and HLX02 (trastuzumab for injection) have been accepted by the State Food and Drug Administration for new drug listing applications and have been included in the priority review process."

Non-US regulatory

A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, PARALLEL ACTIVE-CONTROLLED CLINICAL TRIAL COMPARING PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND EXPLORATORY EFFICACY BETWEEN HLX01 AND EUROPE-SOURCED RITUXIMAB AS A NEW INDICATION IN CHINESE MODERATE TO (EULAR 2019) - "Background: Biologic products, such as rituximab and adalimumab, have revolutionized the treatment for chronic inflammatory disorders, providing an option to patients who were non-responsive to conventional systemic therapies... We report successful demonstration of similarity in PK, safety and initial efficacy between first China-manufactured biosimilar of rituximab, HLX01, and Europe-sourced rituximab in patients with moderately to severely active rheumatoid arthritis. These results support the Phase 3 confirmatory clinical trial for the development of HLX01 for the treatment of rheumatoid arthritis."

Clinical • PK/PD data

CHINA-MANUFACTURED ADALIMUMAB BIOSIMILAR, HLX03, DEMONSTRATED PHARMACOKINETIC EQUIVALENCE AND COMPARABLE SAFETY TO REFERENCE ADALIMUMAB (EULAR 2019) - P1, P3; "PK equivalence and safety similarities between HLX03 and CN-adalimumab were demonstrated which leads to a multi-center, randomised, double-blind, parallel-controlled phase 3 study to further evaluate the efficacy and safety of HLX03 as the proposed biosimilar of adalimumab in patients with moderate-to-severe plaque psoriasis."

Clinical • PK/PD data