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Efficacy, Safety, and Immunogenicity of HLX02 Compared with Reference Trastuzumab in Patients with Recurrent or Metastatic HER2-Positive Breast Cancer: A Randomized Phase III Equivalence Trial

期刊: BIODRUGS, 2021; 35 (3)

Background HLX02 is an approved biosimilar of trastuzumab. Objective This study aimed to evaluated the efficacy, safety, and immunogenicity of HLX02 c......

Efficacy, Safety, and Immunogenicity of HLX04 Versus Reference Bevacizumab in Combination with XELOX or mFOLFOX6 as First-Line Treatment for Metastatic Colorectal Cancer: Results of a Randomized, Double-Blind Phase III Study

期刊: BIODRUGS, 2021; 35 (4)

Plain Language Summary Colorectal cancer (CRC) is the third most common cancer worldwide. Approximately 20% of patients with CRC have metastases at th......

Novel Targeted Biological Agents for the Treatment of Atopic Dermatitis

期刊: BIODRUGS, 2021; 35 (4)

Atopic dermatitis (AD) is a common inflammatory dermatologic disease clinically characterized by intense itch, recurrent eczematous lesions, and a chr......

Demonstrating Analytical Similarity of Trastuzumab Biosimilar HLX02 to Herceptin (R) with a Panel of Sensitive and Orthogonal Methods Including a Novel Fc gamma RIIIa Affinity Chromatography Technology

期刊: BIODRUGS, 2020; 34 (3)

Background A biosimilar needs to demonstrate its similarity to the originator reference product (RP) in terms of structural and functional properties ......

Bispecific Antibodies for Autoimmune and Inflammatory Diseases: Clinical Progress to Date

期刊: BIODRUGS, 2020; 34 (2)

In autoimmune diseases, a highly complex network comprising diverse cytokines and their receptors on immune cells drives the inflammatory response. A ......

A Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of Proposed Biosimilar GB242 and Reference Infliximab in Healthy Subjects

期刊: BIODRUGS, 2019; 33 (1)

The objective of this study was to compare the pharmacokinetics (PKs), safety, and immunogenicity of GB242 as a potential biosimilar infliximab with t......

JIF:4.9

A Global Phase I Clinical Study Comparing the Safety and Pharmacokinetics of Proposed Biosimilar BAT1706 and Bevacizumab (Avastin((R))) in Healthy Male Subjects

期刊: BIODRUGS, 2019; 33 (3)

ObjectiveBAT1706 is a proposed biosimilar of bevacizumab (BEV). The objective of this phase I clinical trial was to establish pairwise similarity betw......

JIF:4.9

Assessing Analytical and Functional Similarity of Proposed Amgen Biosimilar ABP 980 to Trastuzumab

期刊: BIODRUGS, 2019; 33 (3)

BackgroundABP 980 has been developed as a biosimilar to Herceptin((R)) (trastuzumab). Comprehensive analytical characterization incorporating orthogon......

JIF:4.9

Efficacy and Safety of Supportive Care Biosimilars Among Cancer Patients: A Systematic Review and Meta-Analysis

期刊: BIODRUGS, 2019; 33 (4)

BackgroundBiologics are widely used to manage the side effects of cancer treatment (e.g., epoetin alfa is used to treat chemotherapy-induced anemia [C......

JIF:4.9

Efficacy and Safety of Anti-cancer Biosimilars Compared to Reference Biologics in Oncology: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

期刊: BIODRUGS, 2019; 33 (4)

BackgroundMany biosimilars of monoclonal antibodies (mAbs) are becoming increasingly available as anticancer therapies, such as the rituximab, bevaciz......

JIF:4.9

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