Efficacy and Safety of HLX03, an Adalimumab Biosimilar, in Patients with Moderate-to-Severe Plaque Psoriasis: A Randomized, Double-Blind, Phase III Study
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Q. Guo | Xinghua Gao | D. Deng | J. Tao | Li He | Linfeng Li | Hao Cheng | Shanshan Li | Yangfeng Ding | Zhiqi Song | Xiuping Han | Qingyu Wang | S. Geng | Quanzhong Liu | L. Cai | H. Fang | Shifa Zhang | Jianzhong Zhang | Qinping Yang | Jun Zhu | Shenqiu Li | Yan Lu | J. Gu | Zhenshu Biao
[1] Yanpeng Xu,et al. Quality by Design–Based Assessment for Analytical Similarity of Adalimumab Biosimilar HLX03 to Humira® , 2020, The AAPS Journal.
[2] Zhuoli Zhang,et al. Comparison of the Efficacy and Safety of Adalimumab (Humira) and the Adalimumab Biosimilar Candidate (HS016) in Chinese Patients with Active Ankylosing Spondylitis: A Multicenter, Randomized, Double-Blind, Parallel, Phase III Clinical Trial , 2020, BioDrugs.
[3] W. Liao,et al. Safety and Effectiveness of Anti-Tumor Necrosis Factor-Alpha Biosimilar Agents in the Treatment of Psoriasis , 2020, American Journal of Clinical Dermatology.
[4] S. Simoens,et al. The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases , 2020, Drugs.
[5] V. Strand,et al. Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents , 2019, BioDrugs.
[6] Guideline for the diagnosis and treatment of psoriasis in China (2018 complete edition) , 2019, Chinese Journal of Dermatology.
[7] Pantelis K. Vlachos,et al. AURIEL‐PsO: a randomized, double‐blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB11022 to reference adalimumab in patients with moderate‐to‐severe chronic plaque‐type psoriasis , 2019, The British journal of dermatology.
[8] Huji Xu,et al. IBI303, a biosimilar to adalimumab, for the treatment of patients with ankylosing spondylitis in China: a randomised, double-blind, phase 3 equivalence trial. , 2019, The Lancet Rheumatology.
[9] L. Puig,et al. Biosimilars for the treatment of psoriasis , 2019, Expert opinion on biological therapy.
[10] G. Fanjiang,et al. A Review of the Totality of Evidence Supporting the Development of the First Adalimumab Biosimilar ABP 501 , 2019, Advances in Therapy.
[11] He Gao,et al. FRI0086 CHINA-MANUFACTURED ADALIMUMAB BIOSIMILAR, HLX03, DEMONSTRATED PHARMACOKINETIC EQUIVALENCE AND COMPARABLE SAFETY TO REFERENCE ADALIMUMAB , 2019, Poster Presentations.
[12] Jian Wu,et al. FRI0415 BIOSIMILAR BAT1406 VERSUS ADALIMUMAB THERAPY ON ACTIVE ANKYLOSING SPONDYLITIS: A RANDOMIZED, DOUBLE-BLINDED, MULTICENTER, CONTROLLED PHASE 3 TRIAL , 2019, Spondyloarthritis – treatment.
[13] T. Hickling,et al. Immunoassay methods used in clinical studies for the detection of anti‐drug antibodies to adalimumab and infliximab , 2018, Clinical and experimental immunology.
[14] A. Enk,et al. Biosimilars in Dermatology – theory becomes reality , 2018, Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG.
[15] A. Menter,et al. Long-Term Safety and Effectiveness of Adalimumab for Moderate to Severe Psoriasis: Results from 7-Year Interim Analysis of the ESPRIT Registry , 2017, Dermatology and Therapy.
[16] B. Strober,et al. Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double‐blind, multicenter, phase III study , 2017, Journal of the American Academy of Dermatology.
[17] G. Wang,et al. Efficacy and safety of adalimumab in Chinese patients with moderate‐to‐severe plaque psoriasis: results from a phase 3, randomized, placebo‐controlled, double‐blind study , 2016, Journal of the European Academy of Dermatology and Venereology : JEADV.
[18] Carol F. Kirchhoff,et al. Development of biosimilars. , 2016, Seminars in arthritis and rheumatism.
[19] G. Goldenberg,et al. Biologic safety in psoriasis: review of long-term safety data. , 2015, The Journal of clinical and aesthetic dermatology.
[20] I. Olivieri,et al. The use of biosimilars in immune-mediated disease: A joint Italian Society of Rheumatology (SIR), Italian Society of Dermatology (SIDeMaST), and Italian Group of Inflammatory Bowel Disease (IG-IBD) position paper. , 2014, Autoimmunity reviews.
[21] Yue Zhao,et al. Patient considerations and targeted therapies in the management of psoriasis in Chinese patients: role of ustekinumab , 2014, Patient preference and adherence.
[22] Y. Liu,et al. Prevalence of psoriasis in China: a population-based study in six cities. , 2012, European journal of dermatology : EJD.
[23] H. Nakagawa,et al. Adalimumab in Japanese patients with moderate to severe chronic plaque psoriasis: Efficacy and safety results from a Phase II/III randomized controlled study , 2010, The Journal of dermatology.
[24] J. Saurat,et al. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION) , 2007, The British journal of dermatology.
[25] Sung-Jan Lin,et al. Risk Factor Analysis for the Immunogenicity of Adalimumab Associated with Decreased Clinical Response in Chinese Patients with Psoriasis. , 2015, Acta dermato-venereologica.
[27] English Only,et al. GUIDELINES ON EVALUATION OF SIMILAR BIOTHERAPEUTIC PRODUCTS (SBPs) , 2009 .
[28] B. Strober,et al. Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial. , 2008, Journal of the American Academy of Dermatology.
[29] I. Knezevic,et al. [Biological standardization]. , 1972, Harefuah.