Regul Toxicol Pharmacol 2021 Mar 1;122:104912. Epub 2021 Mar 1.
Amgen Inc., One Amgen Drive, Thousand Oaks, CA, USA. Electronic address:
BioDrugs 2021 Apr 7. Epub 2021 Apr 7.
Shanghai Henlius Biotech, Inc., Shanghai, China.
Background: HLX02 is an approved biosimilar of trastuzumab.Objective: This study aimed to evaluated the efficacy, safety, and immunogenicity of HLX02 compared with reference trastuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive recurrent or metastatic breast cancer.Patients And Methods: This randomized, double-blind, phase III study was conducted at 89 centers in China, the Philippines, Poland, and Ukraine. Read More
Br J Clin Pharmacol 2021 Apr 6. Epub 2021 Apr 6.
University of California, Los Angeles, California, USA.
Aim: To evaluate pharmacokinetic equivalence and preliminary safety of the adalimumab biosimilar CT-P17 administered via autoinjector (CT-P17 AI) or prefilled syringe (CT-P17 PFS) in healthy subjects.Methods: This phase I, open-label study (ClinicalTrials.gov: NCT04295356) randomised subjects (1:1) to receive a single 40 mg (100 mg/mL) dose of CT-P17 AI or CT-P17 PFS. Read More
Sci Rep 2021 Mar 29;11(1):7103. Epub 2021 Mar 29.
State Key Laboratory of Bioreactor Engineering, Shanghai Collaborative Innovation Center for Biomanufacturing Technology, East China University of Science and Technology, Shanghai, 200237, China.
Glycosylation is critical for monoclonal antibody production because of its impact on pharmacokinetics and pharmacodynamics. Modulation of glycan profile is frequently needed in biosimilar development. However, glycosylation profile is not a single value like that of cell culture titer, hence making it challenging for the Design of Experiment (DoE) methodology to be directly applied. Read More
Int J Retina Vitreous 2021 Mar 24;7(1):24. Epub 2021 Mar 24.
Clinical Development & Medical Affairs, Intas Pharmaceuticals Ltd. (Biopharma), Ahmedabad, Gujarat, India.
Background: Razumab™ (world's first biosimilar ranibizumab) is approved for several macular disorders including wet age-related macular degeneration (AMD). We evaluated the safety and efficacy of biosimilar ranibizumab in wet AMD.Methods: This prospective, multicentre, rAnibizumab bioSimilar Safety Efficacy postmarkeTing (ASSET) study enrolled patients aged ≥ 50 years with wet AMD having best-corrected visual acuity (BCVA) between 20/40 and 20/320. Read More
Adv Ther 2021 Apr 9;38(4):1889-1903. Epub 2021 Mar 9.
State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.
Introduction: Patients with diffuse large B-cell lymphoma (DLBCL) have limited access to rituximab. IBI301 is a recombinant chimeric murine/human anti-CD20 monoclonal antibody and is a candidate biosimilar to rituximab. This study aimed to assess the therapeutic equivalence of IBI301 and rituximab in previously untreated patients with diffuse large B-cell lymphoma (DLBCL). Read More