Recently, Henlius announced that the results of the Phase 3 study (NCT03316781) of 汉达远®, an independently developed adalimumab biosimilar in psoriasis (Ps) was published in an international journal Advances in Therapy. The results showed that 汉达远® was highly similar to the reference adalimumab in terms of efficacy, safety and immunogenicity. The publication also demonstrated the international peer review recognition of the quality and efficacy of this study.
This multi-centre, randomised, double-blind, parallel-controlled Phase 3 study, aimed to compare the efficacy, safety, and immunogenicity between 汉达远® and reference adalimumab in patients with moderate-to-severe plaque psoriasis. Enrolled patients were randomised 1:1 to receive either 汉达远® or reference adalimumab by subcutaneous injection (80 mg at week 1, 40 mg at week 2, and then 40 mg every 2 weeks) for 48 weeks. The primary endpoint of this study was the improvement in Psoriasis Area and Severity Index score at week 16 (PASIwk16) comparing to baseline. In the full analysis set, the PASIwk16 were 83.5% in the 汉达远® group (n = 131) and 82.0% in the reference group (n = 130), with a least square mean difference of 1.5% (95% CI: −3.9%, 6.8%), which fell entirely in the pre-defined equivalence margins (±15%). The results demonstrated equivalence efficacy between 汉达远® and reference adalimumab with similar safety and immunogenicity profiles, which strongly supported the launch of 汉达远® in China.
As the company's first drug in autoimmune treatment, the development of 汉达远® was strictly followed the NMPA Technical Guidelines for the Development and Evaluation of Biosimilars (Tentative). Different from currently marketed adalimumab biosimilars in China, 汉达远® is the only adalimumab biosimilar evaluated in a Phase 3 clinical study among Chinese patients with Ps, which helps to accumulate valuable clinical evidence among this patient population. In December 2020, 汉达远® was approved by the NMPA for the treatment of rheumatoid arthritis, ankylosing spondylitis and Ps. In April 2021, the sNDA for uveitis of 汉达远® was also approved, further expanding its application in the field of ophthalmic diseases. Looking forward, Henlius will continue cooperating with Wanbang Biopharma to promote the commercialization of 汉达远®, fulfilling unmet bio-treatment needs of patients worldwide.
About Advances in Therapy
Advances in Therapy is an international, peer reviewed, rapid-publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.